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.
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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 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.

Shekhar
Shekhar
Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.

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