39 Ecrf Jobs in Arcot

As a RAVE Database Build Programmer at [Your Company Name], your role will involve designing, building, and managing clinical trial databases using Medidata RAVE. You will collaborate with cross-functional teams to ensure databases align with protocol requirements, maintain high-quality standards, and support the successful execution of clinical studies. Key Responsibilities: - Design and build clinical trial databases in Medidata RAVE. - Create and configure eCRFs (electronic Case Report Forms) and program edit checks. - Implement and test custom functions using C# scripting. - Manage data validation, cleaning, and handling processes. - Perform User Acceptance Testing (UAT) and ensure database accuracy. - Handle protocol amendments, mid-study updates, and database migrations. - Integrate RAVE with other clinical trial systems (e.g., SAS, CTMS). - Manage user roles, permissions, version control, and deployment. - Provide support for audit trail management and compliance. - Troubleshoot and resolve database issues. Qualifications: - 3+ years of experience in clinical database programming, preferably with Medidata RAVE. - Strong understanding of clinical trial processes and data management. - Proficiency in C# for custom function programming. - Experience with query management, edit check programming, and form design. - Familiarity with regulatory requirements (e.g., 21 CFR Part 11). - Excellent problem-solving and communication skills. - Ability to work independently and collaboratively in a fast-paced environment. If you are passionate about clinical research and have a knack for database programming, [Your Company Name] offers you the opportunity to work on cutting-edge clinical trials in a collaborative and supportive team environment. You will also benefit from a competitive compensation and benefits package, along with career growth and development opportunities. We look forward to hearing from you!,

As a React Developer at Arcot Group, you will be responsible for building user-friendly and dynamic web applications using React.js. You will work closely with designers and backend developers to create high-performance applications that deliver exceptional user experiences. Key Responsibilities: - Developing and implementing user interface components using React.js. - Translating designs and wireframes into high-quality code. - Building reusable components and front-end libraries for future use. - Optimizing components for maximum performance across various web-capable devices and browsers. - Collaborating with backend developers to integrate APIs and improve application functionality. - Participating in code reviews and ensuring adherence to best practices. - Keeping abreast of the latest industry trends and technologies. Qualifications Required: - Bachelor's degree in Computer Science, Information Technology, or a related field. - Proven experience as a React Developer or similar role. - Strong proficiency in JavaScript, including ES6+ syntax and features. - Experience with state management libraries (e.g., Redux, Context API). - Familiarity with RESTful APIs and asynchronous programming. - Understanding of front-end development tools such as Webpack, Babel, and NPM. - Excellent problem-solving skills and the ability to work collaboratively in a team environment.,

You are being offered an exciting opportunity to join Arcitech AI as a Python Developer Intern. As part of the dynamic engineering team, you will have a chance to gain hands-on experience, collaborate with skilled professionals, and contribute to impactful projects. Key Responsibilities: - Develop Backend Services: You will assist in developing and maintaining backend services and applications using Python to support business processes and customer-facing solutions. - Collaborate with Cross-Functional Teams: Work closely with data scientists, front-end developers, and system architects to implement robust and seamless solutions. - Code Development: Write reusable, testable, and efficient code that meets project requirements and adheres to best practices. - Integration with Front-End Elements: Help integrate user-facing elements developed by front-end teams with server-side logic. - Data Storage Solutions: Implement and maintain data storage solutions using both SQL (e.g., MySQL, PostgreSQL) and NoSQL (e.g., MongoDB) databases. - Code Reviews and Best Practices: Participate in code reviews and contribute to team discussions on coding standards and best practices. - Stay Updated: Keep up with the latest trends and advancements in Python and related technologies. Qualifications: - Currently pursuing or recently graduated with a degree in Computer Science, Engineering, Information Technology, or a related field. - Basic knowledge of Python programming and its frameworks (e.g., Django, Flask). - Familiarity with web development technologies such as HTML, CSS, and JavaScript. - Understanding of relational and non-relational databases (e.g., MySQL, PostgreSQL, MongoDB). - Knowledge of software development principles and best practices. - Experience with version control systems like Git. - Strong problem-solving skills and a collaborative mindset. In addition to the above job requirements, the preferred skills for this position include: - Experience with API development and integration. - Familiarity with containerization tools such as Docker. - Understanding of Agile methodologies and project management tools like JIRA. - Basic knowledge of cloud computing environments (e.g., AWS, GCP, Azure). Join Arcitech AI's innovative team and contribute to cutting-edge projects while enhancing your skills in Python development and related technologies.,

As the clinical database and data management subject matter expert on Clinical Project Teams, your role involves the following key responsibilities: - Attend Clinical Project Team meetings to gather business need requirements and translate them into technical requirements - Partner with other shared service functions like Safety, Core Lab, etc. to gather business need requirements and translate them into technical requirements - Identify, analyze, propose solutions, and effectively resolve complex data issues by collaborating with the clinical project team members and other shared service functions - Train database End Users (internal and external users) on the database and/or maintain automated database training system - Capture and maintain Database and Systems training records - Assist in FDA and Quality audits related to Clinical Database and Data Management - Lead development and quality control (QC) of data management documents such as data management plans, data review guidelines, and database validation protocols - Follow and implement data management standards and best practices, ensuring Standard Operating Procedures are followed - Contribute to the development and maintenance of Clinical Database systems, including EDC, Edit Checks, Reporting, Study Notifications, Security, etc. In addition to the above responsibilities, you will also: - Partner closely with DM Management, Database Developers/Analysts, and Programmers to drive database and system deliverables - Translate business requirements into technical requirements for eCRFs, edit checks, study notifications, and customizations in the study database - Perform and document functional and/or user acceptance testing on study databases, reports, study notifications, and database customizations - Ensure that appropriate data validation (edit check) specifications and quality control checks are implemented per study needs - Communicate effectively with the Clinical Project Team and other key stakeholders regarding deliverables, timelines, workarounds, etc. - Prioritize deliverables in collaboration with other Data Management team members and DM Management - Work with Biostatistics and Programmers to develop and promote standards in the database and system usage - Process database accounts and review accounts regularly to maintain the integrity of database access and security - Recommend improvements to existing Clinical Data Management practices and procedures, including identifying and suggesting solutions for technology issues Your role also involves leading data cleaning and data freeze/lock efforts for regulatory submissions and other business needs: - Lead data review meetings with the Clinical Project Team and Statistics to identify data cleaning issues and strategize cleaning efforts - Project plan interim and final database lock and data reviews, ensuring timely completion of all data review activities - Coordinate and ensure completion of all aspects of data review, including running validation procedures, issuing queries, database QC, SAE Reconciliation, medical coding, and database closure activities - Design tools and reports to document data review and assist in data cleaning activities - Lead and document data freeze activities with the Clinical Project team, Biostatistics, and SAS programmer - Utilize existing tools/reports, SQL, and database UI to identify data issues and drive resolutions with the Clinical Project Team promptly This comprehensive role requires you to be a proactive and detail-oriented professional with excellent communication and problem-solving skills, capable of collaborating effectively with cross-functional teams to ensure high-quality data management practices and regulatory compliance.,

As a Clinical Data Scientist at Novartis in Hyderabad, your role involves using advanced data management tools and techniques to ensure professional and lean execution of Data Management products and milestones for all assigned trials within Clinical Data Acquisition and Management. Your primary responsibility is to ensure consistently high-quality data is available for analysis and reporting. Key Responsibilities: - Provide data management input on Clinical Trial teams and may act as a Trial Data Scientist on small low complexity trials - Perform data management activities for the startup of a study, including preparing the eCRF, CCGs, Data Quality plan (DQP), Data Quality Plan Module (DQPM), and performing user acceptance testing (UAT) as applicable - Manage local lab setup for the Clinical Database and ensure consistency of assigned trials with program level standards - Understand third party data requirements and new technologies that may be used during clinical trials - Perform ongoing review of all data generated from the clinical study, including Third party and local lab data, and SAE reconciliation - Track eCRF completion, query resolution, and provide data status updates as needed - Develop proposals to resolve issues that may occur during the running of assigned trials - Provide input into Study Specification worksheets if assigned trials need to be outsourced - Have a working knowledge of FDA and ICH guidelines and generate study status reports for Clinical trial team meetings Essential Requirements: - University or college degree in life science, computer science, pharmacy, nursing, or equivalent relevant degree - Strong technical skills - Fluent English verbal and written communication - Ideally, 3 years of experience in Drug Development with at least 2 years in Clinical Data Acquisition & Management Novartis is committed to reimagining medicine to improve and extend people's lives. They aim to become the most valued and trusted medicines company in the world. Novartis values its associates and is driven by them each day to reach their ambitions. Joining Novartis means being a part of a mission to create a brighter future together. Novartis is committed to diversity and inclusion in the workplace, building an outstanding and inclusive work environment with diverse teams representative of the patients and communities they serve. Novartis also provides benefits and rewards to help you thrive personally and professionally. If you're passionate about helping people with diseases and their families and want to be part of a community of smart, passionate individuals, consider joining Novartis. If this specific role is not suitable for your experience or career goals, you can join the Novartis Network to stay connected and learn about future career opportunities.,

As a Site Solutions Executive (PRI) at Premier Research, your role involves coordinating and facilitating all clinical trial activities at the site, ensuring compliance with protocols, GCP guidelines, and local regulations. You will support the Principal Investigator and the site study team to ensure that the clinical trials meet all criteria set by sponsors and regulators. Your key responsibilities will include: - Performing timely data entry of Case Record Forms (CRF) or Electronic CRF (eCRF) in consultation with the PI/Investigator - Maintaining clinical trial-related documents at the site, including the Trial Master File - Coordinating submissions to the ethics committee of protocols, adverse events, and periodic study reports for review - Assisting in scheduling patient investigations and assessments per the instructions of the Principal Investigator - Organizing and coordinating laboratory sample pick-ups and reporting - Creating a database of potential patients for enrollment in the study as per the protocol - Completing all mandated and ongoing training modules and SOPs - Collaborating with the PI to respond to audit findings and implement approved recommendations Qualifications required for this role include: - A Bachelor's or Master's degree in clinical, biological, or mathematical sciences, or a medical/dental degree, or a nursing qualification. Exceptions to this require a minimum of 4 years of experience working at clinical research sites - Good oral and written communication skills in English and at least one local Indian language - Excellent interpersonal skills - Strong coordination, organizational, problem-solving, and analytical skills - Attention to detail and documentation, with a focus on time and data accuracy in the clinical trial context - Familiarity with computer usage and office communication tools Premier Research is committed to helping you grow and excel at work while providing the flexibility and balance your life requires. Your ideas and voice matter here, influencing the way we work and deliver medical innovation that patients are desperate for. Join us at Premier Research and build your future in biotech.,

As a Clinical Data Services Analyst at Accenture, you will be involved in the Clinical Data Management team focusing on the collection, integration, and availability of data at appropriate quality and cost. Your role will include performing data management activities such as discrepancy review, query generation, and resolution. You will also be responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. Additionally, you will help in identifying and raising protocol deviations in the database, performing edit check validation, writing test scripts, and carrying out database validation (UAT) against the specified CRF/ECRF. Your responsibilities will also involve managing clinical data management projects. **Key Responsibilities:** - Develop clinical study databases by building electronic case report forms and programming edit checks as per specifications. - Support any updates or changes to the study database (e.g., Protocol amendments) through the change control process. **Qualifications Required:** - BSc/Master of Pharmacy - 3 to 5 years of experience - Language proficiency in English (International) at an expert level About Accenture: Accenture is a global professional services company with leading capabilities in digital, cloud, and security. With over 699,000 employees serving clients in more than 120 countries, Accenture offers Strategy and Consulting, Technology and Operations services, all powered by the world's largest network of Advanced Technology and Intelligent Operations centers. The company embraces the power of change to create value and shared success for its clients, people, shareholders, partners, and communities. For more information, visit www.accenture.com. In your role, you will be aligned with the Life Sciences R&D vertical at Accenture, where services span across the entire life sciences enterprise. Employees in this vertical work on various sub-offerings like Clinical, Pharmacovigilance & Regulatory, helping leading biopharma companies bring their vision to life by improving outcomes through patient-centric approaches and scientific expertise. **What We Are Looking For:** - Adaptable and flexible individuals - Ability to perform under pressure - Strong problem-solving skills - Detail-oriented approach - Capability to establish strong client relationships If you are a Clinical Database Developer with over 4 years of experience and exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva, etc., this role is ideal for you. You should have extensive experience in database design, edit check programming, custom function programming, and unit testing. Certification in Medidata RAVE study builder would be preferred. Additionally, experience in various modules such as IVRS/RWS integration and Lab administration will be beneficial.,

As a Senior Clinical Data Co-ordinator, your role will involve overseeing and co-ordinating tasks delegated to the study team members. You will be responsible for providing training to new data management personnel on data management processes and procedures. Your key responsibilities will include: - Planning, managing, controlling, and performing data processing and management activities for assigned projects in a timely and accurate manner, adhering to trial Sponsors requirements. - Creating and developing study specifications, implementing, testing eCRF or paper CRF edit checks, and conducting data review and overview listings. - Authoring and reviewing the Data Management Plan (DMP) and designing and reviewing case report forms (CRFs/eCRFs). - Participating in the database design process, including User Acceptance Testing (UAT) and reviewing data to issue and resolve queries. - Assisting Clinical CRO, sponsor, or investigative site with resolving queries and medical coding discrepancies. - Validating electronically captured data efficiently, writing clear queries on missing data, and data points failing pre-defined range checks and logical checks. - Co-operating with the Quality Assurance Department in quality control audits on assigned databases and specifying and reviewing database edit check specifications for assigned studies. - Leading efforts in developing and maintaining standard database integrity checks and defining and monitoring clinical trial data flow and quality control processes in accordance with corporate Standard Operating Procedures (SOPs) and guidelines. - Providing training to new staff, study site, and sponsor personnel on data management processes and procedures, data entry, review with electronic data capture systems, data flow, and quality control processes. - Maintaining and preparing final archival of data management documentation relevant to the assigned clinical trials and assisting the corporate archivist in assembling and archiving such documentation. - Assisting in the recruitment process by conducting interviews and shortlisting the candidates. Desirable Skills and Experience: - Experience in Clinical Data Management is required. Location: Chennai, India Qualification Required: - Bachelors Degree in Pharma Please note that the company details were not provided in the job description.,

Role Overview: As a Python Developer Intern at Arcitech AI, you will play a crucial role in the company's software development, AI, and integrative solutions. This entry-level position offers the opportunity to work on cutting-edge projects, collaborate with a dynamic team, and contribute to the growth of the company. Your main responsibility will involve developing Python applications and optimizing code performance, providing you with valuable industry experience. Key Responsibilities: - Assist in designing, developing, and maintaining Python applications focused on backend and AI/ML components under senior engineer guidance. - Help build and consume RESTful or GraphQL APIs integrating AI models and backend services following best practices. - Containerize microservices (including AI workloads) using Docker and support Kubernetes deployment and management tasks. - Implement and monitor background jobs with Celery, including retries and basic alerting. - Set up simple WebSocket consumers using Django Channels for real-time AI-driven and backend features. - Aid in configuring AWS cloud infrastructure as code, assist with backups, monitoring via CloudWatch, and support AI workload deployments. - Write unit and integration tests to maintain 80% coverage across backend and AI codebases. - Follow Git branching strategies, contribute to CI/CD pipeline maintenance, and automation for backend and AI services. - Participate actively in daily tech talks, knowledge-sharing sessions, code reviews, and team collaboration. - Assist with implementing AI agent workflows and document retrieval pipelines using LangChain and LlamaIndex frameworks. - Maintain clear and up-to-date documentation of code, experiments, and processes. - Participate in Agile practices including sprint planning, stand-ups, and retrospectives. - Demonstrate basic debugging and troubleshooting skills using Python tools and log analysis. - Handle simple data manipulation tasks involving CSV, JSON, or similar formats. - Follow secure coding best practices and be mindful of data privacy and compliance. - Exhibit strong communication skills, a proactive learning mindset, and openness to feedback. Qualifications Required: - Currently pursuing a Bachelors degree in Computer Science, Engineering, Data Science, or related scientific fields. - Solid foundation in Python programming with familiarity in common libraries (NumPy, pandas, etc.). - Basic understanding of RESTful/GraphQL API design and consumption. - Exposure to Docker and at least one cloud platform (AWS preferred). - Experience or willingness to learn test-driven development using pytest or unittest. - Comfortable with Git workflows and CI/CD tools. - Strong problem-solving aptitude and effective communication skills.,

Role Overview: As an IT IAM Security Analyst at Citcos, your primary role involves the development and support of Identity and Access Management (IAM) services. You will be responsible for customizing IAM products such as IDM, Arcot, and Siteminder using SDK libraries. Collaboration with application IT teams to develop API/JDBC interfaces for managing application access and creating a java framework to aggregate user access from applications will also be part of your responsibilities. Additionally, you will work on developing custom flows in Arcot to handle authentication rules for different user groups and handle complex production issues, patching verification, and IAM product upgrades. Interacting with various support and development groups, security team staff, business management, and end-users is an essential part of your duties. Key Responsibilities: - Hands-on experience in CA IDM components like tasks, screens, BLTH, Identity Policy, password policy, and policy xpress - Proficiency in CA Identity Governance, CA Identity Portal endpoint integration, and coding knowledge for connectors - Experience with Core Java, IDM SDK, and customizing connectors - Knowledge of ODSEE/ OUD, LDAP Directory upgrades, and troubleshooting directory issues - Installation and troubleshooting of applications in Unix and Windows environments - Familiarity with Application Servers such as JBOSS, Tomcat, Apache - Troubleshooting and resolving issues related to identities, systems, access, accounts, authentication, authorization, entitlements, and permissions - Providing analysis, development, testing, training, communication, deployment, and maintenance of IAM systems - Documenting processes, procedures, standards, and guidelines related to Information Security - Collaborating with internal stakeholders to identify access management requirements - Working independently, portraying a professional demeanor, and training other staff members and external clients Qualifications Required: - Bachelor's Degree in Computer Science or related field - Graduate Degree is a plus Desired Knowledge/Skills: - Experience with CA Identity Manager or equivalent Provisioning system - Proficiency in CA SiteMinder Administration - Knowledge of Single Sign-On, SAML, and Federation - Experience with CA Strong Authentication support - Familiarity with Privilege Access Management and Certificate Authority,

Role Overview: As an HR Intern at Arcot Group, you will have the opportunity to immerse yourself in the realm of human resources, focusing on recruitment, employee engagement, and organizational culture. This internship offers a valuable experience where you will gain insights into the multifaceted world of human resource management. Your role will involve contributing to our people-centered approach through various responsibilities. Key Responsibilities: - Support the recruitment process by posting job openings, screening applications, coordinating interviews, and aiding in the selection process. - Assist in the onboarding of new employees by preparing onboarding materials, maintaining HR databases, updating employee records, and participating in organizing employee engagement and training programs. - Conduct surveys, collect employee feedback, and provide necessary administrative support to the HR team. Qualifications Required: - Positive attitude and a strong willingness to learn - Excellent communication skills - Ability to work both independently and collaboratively - Basic understanding of HR principles and practices (advantageous) - Proficiency in Microsoft Office tools such as Word, Excel, and PowerPoint Additional Company Details (if available): Join us at Arcot Group for a rewarding internship experience that will pave the way for a successful career in HR.,

You will be responsible for managing customer projects independently with minimal supervision from the management in the Clinical Research Domain. Your key responsibilities will include: - Project Management and Clinical Data Management for the given Project, which involves handling customer projects related to IWRS/EDC/CTMS systems and services. - Customer Management for the given Project. - Monitoring Project Timelines and taking necessary actions to ensure the project stays on track. - Accountable for all Project deliverables towards the customer project. - Serving as a point of contact from SyMetric. - Providing clinical data management support to Clinical Operation Team/Sponsor/Customer and Clinical Data Management Team. - Reviewing all Clinical Data Management Documents such as Protocols, Case Report Forms (CRFs), and Reports. - Developing Data Management Plan (DMP) and Electronic Case Report Form (eCRF). - Creating project specification documents, including eCRF design, user requirements, edit checks, business rules, and data validations. - Coordinating User Acceptance Test (UAT) of eCRF build and validation documents. - Assisting AE/SAE Data Reconciliation in Safety DB and/or SyMetric CDM Database. - Developing Plans for Data Quality in EDC to Database Lock/Unlock, Data Freeze/Unfreeze, and Final Database Lock. - Performing close-out audit for the closing of study trials in SyMetric Clinical Data Management Databases. - Ensuring 100% compliance with SyMetric SOPs. Your technical skills should include proficiency in Microsoft Office Suite, Clinical Data Management System (CDMS) skills, and knowledge of Good Clinical Practice (GCP), Good Clinical Data Management Practice (GCDMP), CDISC, CDASH, and Regulatory Requirements (21 CFR PART 11). Working knowledge of Clinical Database applications like Electronic Data Capture (EDC) and Clinical Data Management System (CDMS) is essential. Understanding Incident Management, Clinical Data Management, and Clinical Trials monitoring experience is highly desirable. You should possess 4+ years of experience in handling projects in Clinical Data Management for clinical trial projects or health sciences-related projects. Working in an IT environment is essential, and Pharma Industry Knowledge is preferable. Individuals who have experience in handling projects in Pharma Industry and CROs, as well as working on IWRS/EDC systems, will be given preference. In terms of competencies, you should have strong intercultural awareness, excellent communication skills in English, effective time management abilities, and experience working in virtual teams when needed. As for education and other qualifications, the ideal candidate should hold a Postgraduate or bachelor's degree in any faculty, preferably in Pharmacy, with specialization in Clinical Data Management methodologies. IT Service management skills are preferred.,

Role Overview: Join our R&D division at Mirror Institute for Embedded Technology (MIET) in Chennai to learn, design, and innovate in VLSI and Embedded Technologies. You will have the opportunity to gain hands-on experience with FPGA/ASIC Design, Verilog/SystemVerilog, Xilinx & Mentor Graphics tools, and work on industry-grade projects. Additionally, there is the potential for growth as a trainer, researcher, and innovator in advanced chip design and verification domains. Key Responsibilities: - Learn and work on FPGA/ASIC Design projects - Utilize Verilog/SystemVerilog and C/C++ for coding - Work with Xilinx Vivado, ModelSim, Altera Quartus tools - Engage in effective communication and mentoring - Demonstrate a passion for learning and innovation Qualification Required: - M.E. in VLSI Design / Embedded Systems / Power Systems / Power Electronics or M.Sc. in Electronics - Candidates from Anna University, Tamil Nadu (Regular) are preferred - Freshers & Experienced candidates are welcome - Academic criteria: Minimum 70% in UG and 65% in 10th & 12th grades Additional Company Details: Mirror Institute for Embedded Technology (MIET) is located at 184/2, 3rd Floor, Chandamama Building, Arcot Road, Vadapalani, Chennai 600026. Our office is situated conveniently opposite Kamala Theater, above Viveks Showroom. MIET emphasizes a collaborative and innovative environment where employees have the opportunity for professional growth and skill development. For further inquiries or to apply, please contact us at hrmirrorinstitute@gmail.com or call 93809 48474 / 93819 48474. This is a full-time position with a contract term of 3 years. Work location is in person.,

As a fresher with an undergraduate degree between April 2022 to 2024, you have the opportunity to apply for a remote full-time position with the following key skills: - Basic knowledge of XML/HTML and CSS is a must - Familiarity with Microsoft Word, Excel, and PDF tools The job is located in Ranipet, Vellore, Kaveripakkam, Katpadi, Arcot, or Visharam. The application deadline for this position is June 27, 2025.,

**Job Description:** As an HR Manager, you will play a crucial role in the strategic planning of the organization by collaborating with senior leadership to develop and implement HR strategies that align with the overall goals of the company. **Key Responsibilities:** - Develop and update HR policies and procedures to ensure compliance with laws and regulations. - Oversee the recruitment process, including job postings, interviews, and onboarding of new employees. - Implement training programs and career development initiatives to enhance employee skills and job satisfaction. - Design and manage performance evaluation systems to measure and improve employee productivity. - Develop and administer competitive compensation packages and employee benefit programs. - Address employee concerns, mediate conflicts, and foster a positive work environment. - Ensure compliance with labor laws, regulations, and industry standards. - Utilize HR analytics to make informed decisions about workforce planning and talent management. - Lead organizational change initiatives and help employees adapt to new processes or structures. **Qualifications Required:** - Bachelor's degree in Human Resources or related field. - Proven experience as an HR Manager or similar role. - In-depth knowledge of labor laws and regulations. - Strong leadership and communication skills. - Ability to analyze data and make strategic decisions. - Experience in change management is a plus. *Note: This job is full-time with benefits including cell phone reimbursement, provided food, and provident fund. The schedule is a day shift with a yearly bonus. The work location is in person.*,

Were Hiring  for Statistical Programmer (Healthcare Domain) ! Exciting Opportunity Awaits! Location: Mumbai , Chennai , Pune , Bangalore  Salary: Up to 22 LPA Shift: General Shifts Working Days: 5 Days WFO | 2 Rotational Offs Eligibility:Minimum 5 years of experience in Statistical Programming(R,SDTM,ADAM,SDLC) within the Healthcare domain Share your CVs: hrwfm.consultancy42@gmail.com Contact: Shruti 9911988551 References are highly appreciated!

As a Senior Clinical Data Manager I at Allucent, you will play a crucial role in leading data management activities within the Allucent Data Management (DM) department. Your responsibilities will include managing, coordinating, reviewing, and approving DM deliverables from database design & set-up to database locking. It is essential to ensure the completeness, accuracy, and consistency of clinical data meeting quality standards and regulatory requirements. Additionally, you will provide expertise in data management areas, contribute to cross-functional initiatives, and participate in Request for Proposals (RFPs) and Business Development (BD) Meetings. Your key tasks will involve: - Leading and acting as the primary contact for DM with relevant internal and external parties - Planning and projecting required resources, managing tasks, timelines, risks, and quality - Developing, reviewing, and maintaining project-specific DM documents - Leading the development of clinical study database set-up, eCRF design, and database validation requirements - Creating training materials for EDC users and delivering project-specific training - Overseeing data cleaning strategy, data releases, data transfers, and reconciliation activities - Providing project metric reports, status updates, study progress, and feedback - Maintaining DM study documentation, supporting audits, and aligning data management best practices - Participating in client evaluations, preparing proposals, and staying updated on regulatory trends Qualifications required: - Life science, healthcare degree, and/or a combination of education and experience - Minimum 5 years of relevant work experience as a Clinical Data Manager - Thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and local/regional requirements - Experience with EDC software systems, IRT, eCOA, and CDISC conventions - Strong written and verbal communication, organizational, negotiating, and motivational skills - Ability to work in a fast-paced environment and proficiency with computer applications Joining Allucent offers the following benefits: - Comprehensive benefits package - Competitive salaries - Departmental Study/Training Budget for professional development - Flexible working hours and remote/office-based working opportunities - Leadership and mentoring opportunities - Internal growth opportunities, employee referral program, and access to online training platforms (Note: This position is for the Chennai Location and not home-based),

**Job Description** As a Technical Data Manager at Excelya, you will play a crucial role in performing Technical Data Management tasks to high regulatory standards and Excelya Group SOPs. Your responsibilities will include: - Designing CRF (Unique) in the EDC database, screens design, writing Data Validation Plans, programming edit checks in EDC database, and writing listings specifications as per study specifications - Collaborating closely with the Data Manager & Lead Data Manager for the study - Maintaining global libraries in EDC database - Participating in study documentation and keeping technical specifications documents updated - Adhering to internal technical QC and document updates - Completing Excelya administrative tasks such as timesheets, CV and training updates, and ensuring compliance with customer trainings - Undertaking other assigned tasks from the supervisor related to Excelya and the customer - Strictly following Excelya and Client's SOPs, guidelines, and relevant legislation - Working under the supervision of more senior staff (Manager or Senior TDM) **Qualifications Required:** - Bachelor's degree in a Scientific field preferred - 2-3 years of experience as a Technical Data Manager or equivalent - Knowledge of ICH GCP and other relevant guidelines for regulatory compliance - Familiarity with CDM best practices and associated documentation - Experience in clinical trial databases, data flow, data review, eCRF Report Form design, and Edit checks designing as per specifications - Understanding of clinical trials lifecycle - Proficiency in computer technology (Word, Excel, PowerPoint, MS Project) - Knowledge of Java Script and programming best practices - Fluency in local language and English (written and spoken) **Additional Company Details:** At Excelya, passion for science and teamwork is combined to redefine excellence in healthcare. The company, with over 900 professionals, aims to become Europe's leading mid-size CRO with the best employee experience. By offering full-service, functional service provider, and consulting, Excelya enables employees to work on diverse projects alongside industry experts to enhance scientific, operational, and human knowledge for the benefit of patient care. Excelya values audacity, care, and energy, providing an environment that nurtures talent and encourages contribution to the shared mission.,

As a fresher in the field of research and regulatory affairs, you will be responsible for completing appropriate role-specific training to perform job duties. Under supervision, you will assist in various administrative tasks to support team members in project execution. This may include running system reports, maintaining meeting minutes, preparing and distributing status reports, creating and managing study documents, and more. - Assist in various administrative tasks to support team members in project execution - Run system reports, maintain meeting minutes, prepare and distribute status reports - Create and manage study documents Your role will also involve updating and maintaining systems within project timelines and per project plans. Ensuring the accuracy and completeness of source documents, CRFs, Investigator Site File, and other study-related documents according to ICH-GCP guidelines will be crucial. Additionally, you will be responsible for completing the eCRF and maintaining Investigational Product integrity based on specific temperature requirements. - Update and maintain systems within project timelines and per project plans - Ensure accuracy and completeness of study-related documents according to ICH-GCP guidelines - Complete eCRF and maintain Investigational Product integrity Furthermore, you will play a vital role in preparing for site qualification visits, initiation visits, monitoring visits, and site close-out visits. Organizing ethics committee meetings, completing review forms, and submitting all study-related documents to EC will also be part of your duties. You may need to coordinate with local and central labs, assist in Safety Reporting within required timelines, contribute to patient selection and recruitment processes, and support the Informed Consent Process. - Prepare for various site visits and meetings - Coordinate with local and central labs - Support Safety Reporting and patient recruitment processes To excel in this position, you should possess basic knowledge of applicable research and regulatory requirements such as ICH GCP and relevant local laws, regulations, and guidelines. Proficiency in MS Applications like Microsoft Word, Excel, and PowerPoint is essential. Strong written and verbal communication skills in English, effective time management abilities, and a results-oriented approach to work delivery will be critical for success. - Possess basic knowledge of research and regulatory requirements - Proficiency in MS Applications - Strong communication skills and time management abilities Moreover, you should be capable of establishing and maintaining effective working relationships with coworkers, managers, and clients. Strong listening and phone skills, as well as good data entry abilities, are also required to fulfill the responsibilities of this role. - Establish and maintain effective working relationships - Possess strong listening and phone skills - Have good data entry abilities **Qualifications Required:** - Educational backgrounds in B.Tech, M.Tech (Biotechnology), MSc (Biotechnology, Microbiology, Biochemistry), B.Pharm, M.Pharm, Pharm D, MSc, and BSc (Life Science: Bioinformatics, Biomedical Engineering, etc.) from the years 2016 to 2019 are encouraged to apply for this position.,

As a Clinical Data Associate / Clinical Data Coordinator at Imaging Endpoints, your role involves conducting all clinical data management activities for each assigned clinical study. This includes coordinating with study team members, management, and clients to complete work as detailed in the clients" work order. You will be responsible for maintaining audit readiness by ensuring study-related documents are in the study eTMF in a timely manner, effectively communicating project status to internal and external stakeholders, and conducting clinical data management activities per relevant standard operating procedures and work instructions as directed by management. Additionally, you will perform data processing of project data, such as conducting quality control review and entering data into electronic data capture systems. Responsibilities: - Assist in processing radiological images received for client projects in accordance with standard operating procedures. - Enter clinical trial data into data collection tools. - Conduct quality control review of clinical trial data. - Conduct data review of CRFs, eCRFs, reports, or data listings. - Generate, track, and close queries for images, reports, CRFs, eCRFs. - Conduct data/image transfers. - Monitor radiology readers for applicable on-site reads. - Track conduct of DE/QC activities. - Generate and/or quality control review Diagnostic and Summary Reports. - Support data analysis activities. - Support database lock activities. - Support study closeout and reconciliation activities. - Conduct UAT activities for data collection and transfer systems/tools. - Maintain both paper and electronic project files in accordance with standard operating procedures. - Advocate compliance with all standard operating procedures. - Contribute to the generation of Study Specific Procedures (SSPs). - Contribute to the generation of study-specific reports. - Contribute to the generation of study-specific data collection tools/databases. - Assist Clinical Data Managers with any requested task. - Assist with training and monitoring of Clinical Data Coordinator I. - Update appropriate study team members and management with task, deliverable, and project statuses. Qualifications: - Bachelor's Degree required or equivalent combination of education and relevant work experience. - At least 1 year of prior clinical data management experience required. - Intermediate knowledge of analysis software such as SAS preferred. - Understanding of database development, especially electronic data capture systems used in clinical trials. - Knowledge of Good Clinical Practices. - Working knowledge of medical terminology required. - Knowledge of clinical trials and/or healthcare industries required. - Expertise in using MS Office and internet applications required. Imaging Endpoints is dedicated to revolutionizing imaging science and technology to bring curative technologies to humankind. Join our global team and contribute to advancing clinical trials and helping patients in need.,