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WFH Clinical Data Jobs at Thermo Fisher Scientific - Apply Now

Fully Remote/WFH Clinical Data Team Lead Job at Thermo Fisher Scientific – Apply Now

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WFH Clinical Data Jobs at Thermo Fisher Scientific - Apply Now Clinical Data Team Lead Location: Remote, India Job ID: R-01280267 Job Type: Full time Category: Clinical Research Remote: Fully...

Biotecnika Times Newsletter 03.12.2024 – IISc Non-NET Jobs, Paid Internship at HaystackAnalytics, Govt Silk...

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IISc Teaching Assistants Recruitment – Non-NET Candidates Apply Online Explore teaching assistant positions at IISc. Great opportunity to build your academic career! Paid Intern R&D Opportunity...
Aurigene Oncology Life Sciences Jobs - Apply For Research Vacancies

Aurigene Oncology Hiring – Research Associate/Scientist Position Available Now!

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Aurigene Oncology Life Sciences Jobs - Apply For Research Vacancies Position: Research Associate/Scientist - Cell and Gene Therapy (Manufacturing) Duration: JUN 2024 - JUN 2025 Location: India Desired...
Syneos Health CDM Jobs - BSc Biological Sciences Apply Online

Syneos Health Clinical Data Associate Job Opening for BSc, Apply Online

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Syneos Health CDM Jobs - BSc Biological Sciences Apply Online CDA II Location: India-Asia Pacific - IND-Home-Based Job ID: 24006411 Description Clinical Data Associate II Syneos Health® is a leading,...
Biomedical Engineering Research Analyst at GHX, Apply Now!

Biomedical Engineering Research Analyst at GHX, Apply Now!

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Biomedical Engineering Research Analyst at GHX, Apply Now! Research Analyst Location: Hyderabad, Telangana, India Job Description: What you will be doing: As a Research Analyst, you will: Obtain, review,...
ICON plc Life Sciences Vacancies

Hybrid Vacancy, Apply at ICON plc For Clinical Trial Assistant Job

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ICON plc Life Sciences Vacancies, Apply For Clinical Trial Assistant Job Clinical Trial Assistant Location: Chennai Job ID: JR120814 Category: Clinical Trial Support Type: ICON Full Service & Corporate...
Top 10 Gene Therapy Companies

Top 10 Leading Biotech Companies Revolutionizing Gene Therapy Research

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Top 10 Gene Therapy Companies in the World Are You Aware of the fact that over 350 million people worldwide live with rare genetic disorders,...
Remote CDM Position Labcorp - Role at Fortrea (Labcorp), Apply Now

Remote Clinical Data Manager Role at Fortrea (Labcorp) Position – Apply Now

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Remote CDM Position Labcorp - Role at Fortrea (Labcorp), Apply Now Associate Clinical Data Manager Locations: Bangalore, India Remote, India Time Type: Full-time Posted On: Posted Today Time Left...
Clinical Project Assistant at Sanofi! Apply Now! Clinical Project Assistant Location: Hyderabad Job Type: Permanent and Full Time Travel: As per business needs Application Deadline: December 30, 2024 Job Requisition ID: R2772756 About the Job Our Team: Sanofi Business Operations (SBO) is a centralized internal resource organization in India, supporting various functions globally, including Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D. The SBO aims to develop internal expertise, reduce reliance on external service providers, and leverage the talent pool effectively. Main Responsibilities: The Clinical Project Assistant (CPA) will provide support in the following areas: eTMF and Documentation Management: Support the Registries team in setting up and administering electronic Trial Master File (eTMF) while adhering to protocols, GCP guidelines, and SOPs. Handle the TMF archiving process, including preparation, collection, reconciliation, and filing of relevant documents. Manage document uploads for all existing and new sites and ensure primary Quality Control (QC). Project Management: Provide administrative support for project management activities. Coordinate project schedules, ensure timely updates on milestones, and collaborate with the Registries team. Develop and maintain relevant sections of Registry materials. Support budget tracking and site payments as required. Communication and Coordination: Prepare correspondence, including meeting minutes, for the project team or customers. Manage and coordinate core file reviews and support audits. Manage project-specific e-training tracking and oversee compliance. Coordinate onboarding of new key project team members and system access. Update and maintain Registries SharePoint. Miscellaneous Tasks: Perform miscellaneous administrative tasks as necessary. People Responsibilities: Collaborate with the study team to conduct registries from start-up to closure. Interact with Clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), and site staff to ensure timely completion of administrative tasks. Performance Responsibilities: Maintain registry study documents. Conduct routine QC checks of registry study documents. Process Responsibilities: Set up and manage the eTMF system for registries. Keep local trial master files (paper & electronic) up to date in collaboration with CPLs and CRAs. Manage document uploads for all sites and ensure proper QC. Classify documents correctly in the eTMF system. Ensure TMF compliance and inspection readiness. Track the volume of documents uploaded. Oversee TMF archiving, including preparation, collection, reconciliation, and filing. Stakeholder Responsibilities: Commit to Customers: Understand and exceed stakeholder expectations to enhance Registry study functions. Collaborate Across Functions: Work effectively with peers, stakeholders, and partners to improve Registry study efficiency. About You Experience: 3+ years of clinical research experience, including eTMF document management. Understanding of ICH-GCP guidelines and clinical trial methodologies. Soft Skills: Excellent written and oral communication skills. Strong eTMF management skills. Confidentiality in handling data and information. Effective relationship management with sites and study teams. Technical Skills: Attention to detail and methodical task prioritization. Understanding of ICH-GCP principles and local regulatory requirements. Proficiency with emerging technologies and mobility applications. Competency with Microsoft Office products. Education: Bachelor’s degree in life sciences or a related field. Languages: High proficiency in written and spoken English. Link to Apply: APPLY ONLINE HERE GOT HIRED THROUGH BIOTECNIKA? LET US KNOW BY CLICKING HERE AND WIN SOME PRIZE! Keywords: Sanofi, Clinical Project Assistant, eTMF, Clinical Research, ICH GCP, Hyderabad, Job Opening. Clinical Project Assistant at Sanofi! Apply Now! Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.

Clinical Project Assistant at Sanofi! Apply Now!

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Clinical Project Assistant at Sanofi! Apply Now! Clinical Project Assistant Location: Hyderabad Job Type: Permanent and Full Time Travel: As per business needs Application Deadline: December 30, 2024 Job Requisition...
Clinical Trial Associate Jobs at Dr. Reddy’s, BSc, MSc & Diploma Candidates Apply

Dr. Reddy’s Hiring For Clinical Trial Associate Position – BSc, MSc & Diploma Candidates...

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Clinical Trial Associate Jobs at Dr. Reddy’s, BSc, MSc & Diploma Candidates Apply Clinical Trial Associate Location: Hyderabad, Telangana, India About the job Company Description Dr. Reddy’s Laboratories Ltd....

Biotecnika Times Newsletter 13.11.2024 – Hybrid Microbiology Jobs at Novonesis, Clinical Data Management Jobs...

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Hybrid Microbiology Executive Position at Novonesis – Apply Online Apply for a hybrid Executive role in microbiology at Novonesis, ideal for candidates eager to work...
Fortrea Clinical Data Management Position Available - Apply Online

Clinical Data Management Position at Fortrea (LabCorp Spin-off) – Apply Online

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Fortrea Clinical Data Management Position Available - Apply Online Clinical Data Specialist Location: Bangalore, India Time Type: Full time Job Requisition ID: 2440541 As a leading global contract research...
Parexel Clinical Data Analyst Job - Apply Online

Hybrid Clinical Data Analyst Role at Parexel! Apply Now

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Parexel Clinical Data Analyst Job - Apply Online Clinical Data Analyst II Location: Hyderabad, India Job ID: R0000029152 Category: Data Management About this Role The Clinical Data Analyst II (CDA...

Biotecnika Times Newsletter 11.11.2024 – Freshers SJRI Jobs, Govt IPC & CCRAS Vacancies, NEW...

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Freshers Jobs at SJRI Bengaluru – Apply Online For Project Role Apply for freshers' project role at SJRI Bengaluru. Online applications are now open for...
MakroCare Clinical QA Job For BS & MSc - Apply Online

MakroCare Clinical QA Job For BS & MSc – Apply Online

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MakroCare Clinical QA Job For BS & MSc - Apply Online Quality Assurance (Clinical QA) - Associate Location: Hyderabad, Telangana, India About the Job Department: QA - MakroCare...
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