Sanofi BSc Life Sciences Jobs
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Sanofi BSc Life Sciences Jobs – Apply For Clinical Project Assistant Role

Clinical Project Assistant

Hyderabad, India

Permanent

Posted on: Nov. 18, 2024

Closing on: Dec. 30, 2024

Hiring Manager: Project Lead – ESR and Grants

Location: Hyderabad

% of travel expected: Travel required as per business need

Job type: Permanent and Full-time

About the job

Our Team:

Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India, set up to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions​. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations​ globally.

Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. It leverages an untapped combination of talent pool.

Main Responsibilities:

The Clinical Project Assistant (CPA) will support the following:

  • Provide support to the Registries team for the setup and administration of electronic Trial Master File (eTMF) ensuring adherence to protocol, Good Clinical Practices (GCP) guidelines, and company Corporate and Local Standard Operating Procedures (SOPs).
  • Responsible for TMF archiving process, including preparation of archiving, collection, reconciliation, and filing of relevant documents.
  • Manage the upload of documents for all existing and new sites and ensure a primary Quality Control (QC).
  • Provide administrative support with project management activities.
  • Coordinate the project schedule, ensure timely updates of key milestones, and partner with the Registries team.
  • Develop and maintain relevant sections of various Registry materials.
  • Support project budgetary tracking and site payments as needed.
  • Prepare correspondence, including meeting minutes, for the project team and/or customer.
  • Manage and coordinate core file reviews and support audits as needed.
  • Manage project-specific e-Training tracking and oversee compliance.
  • Coordinate and support onboarding of new Key Project Team Members and system access.
  • Update and maintain Registries SharePoint.
  • Perform miscellaneous administrative tasks as necessary.

People:

  • The CPA is part of the study team and collaborates with the people involved in the conduct of the registries from start-up to closing and archiving activities.
  • CPA interacts with the Clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), and site staff to ensure all administrative tasks are completed on time.

Performance:

  • Maintain registry study documents.
  • Conduct routine QC checks of registry study documents.

Process:

  • Responsible for the eTMF setup system for the Registries.
  • Set up, manage, and keep the local trial master files (paper & electronic) up to date in collaboration with the CPL and CRAs, ensuring compliance with applicable SOPs for filing trial documents for prompt presentation during audits and inspections.
  • Manage document uploads for all existing and new sites and ensure primary QC.
  • Ensure correct and proper classification of the documents in the eTMF system.
  • Control study team compliance to ensure TMF inspection-readiness at any time.
  • Track and ensure the completion of document uploads in the system.
  • Responsible for TMF archiving process, including preparation of archiving, collection, reconciliation, and filing of relevant documents.

Stakeholder:

  • Commit to Customers: Understand, meet, and exceed internal and external stakeholders’ expectations to create positive impact through the evolution of the Registry study function.
  • Cooperate Transversally: Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact Registry study efficiency and execution.

About You:

Experience:

  • 3+ years of experience in clinical research and development, including clinical trial eTMF document management.
  • Understanding of ICH GCP guidelines and clinical trial methodologies required.

Soft Skills:

  • Excellent written and oral communication skills.
  • Excellent eTMF management skills.
  • Ability to maintain confidentiality of data and information during interactions with study staff at all levels and across studies and sponsors.
  • Effective relationship management with sites and study teams.

Technical Skills:

  • Good attention to detail.
  • Methodical approach to work and task prioritization.
  • Understanding of the principles of ICH-GCP and applicable local regulatory requirements.
  • Comfort with emerging technologies and mobility applications.
  • Strong cross-functional collaboration skills and experience.
  • Competent with Microsoft Office products.

Education: A bachelor’s degree in life sciences or a related field.

Languages: High proficiency in written and spoken English.

APPLY ONLINE HERE

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