clinical-site-management-jobs-in-surat, Surat

1 Clinical Site Management Jobs nearby Surat

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posted 5 days ago

Clinical data management

Refined Reports Data
experience2 to 6 Yrs
location
Surat, Gujarat
skills
  • Clinical Data Management
  • Training
  • Life Sciences
  • Communication
  • Teamwork
  • Clinical Trial Data
  • Regulatory Standards
  • FDA Guidelines
  • Data Quality Checks
  • Data Reports
  • Data Transfer
  • Attention to Detail
  • ProblemSolving
Job Description
Role Overview: As a Clinical Data Manager, you will be responsible for overseeing the collection, validation, and analysis of clinical trial data. Your main focus will be to ensure compliance with regulatory standards, such as FDA guidelines, and collaborate with cross-functional teams to meet project timelines. Key Responsibilities: - Manage and maintain clinical trial databases effectively. - Perform data quality checks and resolve any discrepancies identified. - Generate and review clinical data reports for accuracy and completeness. - Coordinate the smooth data transfer between clinical sites and sponsors. - Conduct training sessions on data management processes for team members. Qualifications Required: - A bachelor's and master's degree in life sciences or a related field. - Strong knowledge of clinical trial processes and regulations. - Attention to detail and excellent problem-solving skills. - Effective communication and teamwork abilities. (Note: No additional details about the company were provided in the job description.),
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posted 2 weeks ago

Clinical Data Analyst

Cliantha Research Limited
experience1 to 5 Yrs
location
Ahmedabad, Gujarat
skills
  • Data Management
  • Data Validation
  • Data Entry
  • Database Management
  • Medical Coding
  • UAT Testing
  • Quality Review
  • Query Generation
  • SOP Compliance
Job Description
Role Overview: You will be responsible for creating, maintaining, and updating study-specific documents such as Data Management Plan, Data Validation Plan, study-specific procedures, and data reconciliation plan. Additionally, you will design Case Report Forms for paper and EDC studies, perform data entry in the database, coordinate with other study team members for data management tasks, and ensure data integrity by creating and testing UAT data in the study database. Key Responsibilities: - Train clinical sites on using the study-specific database for EDC studies - Identify and resolve data discrepancies through computerized and manual checks - Perform Quality Review of live data and apply level 1 corrections to the database - Generate queries, update and verify received DCFs and Ex-DCFs - Handle external data, perform external data reconciliation, and resolve related queries - Reconcile Serious Adverse Events (SAE) and resolve SAE queries - Perform Medical Coding of terms reported on Case Report Form - Adhere to Standard Operating Procedures, work procedures, and project scope to ensure quality - Maintain documentation of training and collaborate with other project team members such as the External team, Programmer, Statistician, Monitor, and CRA - Conform to the training schedule, maintain awareness of SOP content in the Data Management team, and comply with company requirements Qualifications Required: - Master's degree preferred - Minimum of 1 year of total work experience required Company Details: No additional details of the company were mentioned in the job description. Note: This is a full-time, permanent position located in Ahmedabad. Health insurance and Provident Fund benefits are provided. Applicants are required to answer specific application questions regarding relocation to Ahmedabad and previous experience in Clinical Data Management. The work location is in person.,
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posted 2 months ago

Distribution and Supply Associate

JUPITER RESEARCH SERVICES INC
experience2 to 6 Yrs
location
Ahmedabad, Gujarat
skills
  • Communication
  • Customer Service
  • Sales
  • Supply Chain Management
  • Logistics
  • Distribution
  • Inventory Control
Job Description
Role Overview: As a Distribution and Supply Associate at Jupiter Research Services Inc in Ahmedabad, you will be responsible for managing distribution, inventory control, communicating with stakeholders, providing customer service, and supporting sales operations on a full-time on-site basis. Key Responsibilities: - Manage distribution of products efficiently - Maintain inventory control to ensure accurate stock levels - Communicate effectively with stakeholders regarding supply chain activities - Provide excellent customer service to clients and partners - Support sales operations by coordinating supply chain activities Qualifications Required: - Proficiency in distribution and inventory control - Strong communication and customer service skills - Sales experience would be advantageous - Attention to detail and strong organizational skills - Ability to collaborate effectively within a team - Experience in supply chain management or logistics - Knowledge of the clinical trial industry would be a plus - Bachelor's degree in Business, Science, Logistics, or a related field (Note: No additional details about the company were mentioned in the job description provided.),
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posted 2 months ago
experience0 to 4 Yrs
location
Ahmedabad, Gujarat
skills
  • patient recruitment
  • screening
  • enrollment
  • data entry
  • document management
  • inventory management
  • communication
  • teamwork
  • adherence to protocols
  • clinical trial processes
  • regulatory knowledge
  • attention to detail
  • organizational skills
  • interpersonal abilities
Job Description
As an Assistant in this role, you will assist in the coordination and conduct of clinical trials under supervision. Your key responsibilities will include: - Supporting patient recruitment, screening, and enrollment according to protocol criteria - Scheduling and managing patient visits, sample collection, and follow-ups - Collecting and accurately entering data into Case Report Forms (CRFs) or Electronic Data Capture (EDC) systems - Maintaining essential documents in the Investigator Site File (ISF) - Ensuring adherence to study protocols, ICH-GCP, and regulatory requirements - Assisting in the preparation for audits or monitoring visits - Communicating with sponsors, CROs, and ethics committees as needed - Ensuring timely reporting of adverse events and protocol deviations - Supporting inventory management of study drugs, lab kits, and trial materials Qualifications required for this position include: - Background in healthcare, life sciences, or related field - Knowledge of clinical trial processes and regulations - Strong attention to detail and organizational skills - Good communication and interpersonal abilities - Ability to work effectively in a team environment (Note: No additional details of the company were mentioned in the provided job description),
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posted 2 months ago

Site CRA

Cliantha Research
experience2 to 6 Yrs
location
Ahmedabad, Gujarat
skills
  • Consumer Research
  • Training
  • Coordination
  • Audit
  • Quality Assurance
  • Regulatory Guidelines
  • Investigator Qualification
  • Documentation Management
  • Monitoring Visits
  • Source Document Verification
  • Study Updates
  • IP Accountability
  • Clinical Trial Supplies Management
  • Site Closeout
  • ICH GCP
Job Description
As an Officer/Sr. Officer in the Consumer Research Department at our company based in Ahmedabad, your role involves: - Identifying and qualifying potential investigators for research studies. - Collecting necessary documents to assess site/investigator feasibility and obtain approval from authorities. - Training the site study team, maintaining essential documents, and overseeing startup activities and site initiation. - Conducting monitoring visits to ensure compliance with study management, protocol, and other requirements at all assigned sites. - Performing source document verification as per the monitoring plan to maintain accurate and up-to-date trial records. - Coordinating with labs and other trial-related services as needed and ensuring IP accountability and availability. - Managing all clinical trial-related supplies, including tracking, shipping, and vendor management. - Handling site closeout and follow-up activities to maintain proper documentation. - Assisting with site audits and liaising with Quality Assurance personnel to ensure compliance with ICH GCP and regulatory guidelines. Basic qualifications required for this role are B. Pharm/M. Pharm/M. Sc with 2-4 years of relevant experience. If you are interested in this opportunity, please send your resume to apurohit@cliantha.com.,
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posted 2 days ago
experience8 to 12 Yrs
location
Ahmedabad, Gujarat
skills
  • Clinical Trials
  • Project Management
  • Regulatory Compliance
  • Protocol Design
  • Data Analysis
  • Quality Assurance
  • Process Optimization
  • Team Development
  • Collaboration
  • Communication Skills
  • Feasibility Lead
Job Description
Role Overview: As the Feasibility Lead in Clinical Trials, your main responsibility will be managing and delivering comprehensive feasibility assessments for early-phase clinical trials. You will ensure the scientific, operational, and regulatory viability of proposed sites and countries, as well as support proposal development through collaboration with internal stakeholders and external clients. Your role will involve leading feasibility planning and execution, driving data-driven site and country selection strategies, and serving as a subject matter expert in feasibility best practices. Key Responsibilities: - Lead feasibility planning and execution to support project bids and early engagement efforts. - Drive data-driven site and country selection strategies. - Provide strategic input on protocol design, country, and site selection. - Stay updated on global feasibility trends and regulatory guidelines. - Guide teams on interpreting feasibility data in line with business objectives. - Contribute to process improvement initiatives and knowledge sharing activities. - Lead feasibility components across multiple projects to ensure timely and high-quality deliverables. - Develop and present regular updates, dashboards, and ad hoc reports for internal and external stakeholders. - Ensure compliance with ICH-GCP, company SOPs, and regulatory frameworks. - Participate in internal audits and implement corrective actions as necessary. - Contribute to the creation and refinement of SOPs related to feasibility. - Support the onboarding and mentoring of new or junior team members. - Foster a collaborative work environment and facilitate cross-functional knowledge sharing. - Participate in resource planning discussions to support strategic growth. Qualification Required: - Education: Bachelor's degree in Pharmacy (mandatory); higher degrees in life sciences or clinical research are a plus. - Experience: Minimum 8 years of relevant experience in clinical trial feasibility or clinical development, with exposure to feasibility planning for early-phase clinical trials (Phase I/II) and global clinical trials preferred. - Technical Competencies: Strong understanding of clinical development and regulatory landscapes, proficiency in feasibility platforms, site databases, and data analytics tools, as well as CRM tools and Microsoft Office Suite (Excel, PowerPoint, Outlook). - Behavioural Competencies: Strong decision-making and problem-solving abilities, effective communication and interpersonal skills, coaching and mentoring mindset, ability to collaborate across functions and lead without direct authority.,
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