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    Clinical Project Assistant

    Sanofi
    3+ years
    Not Disclosed
    Hyderabad
    10 Dec. 13, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Clinical Project Assistant (CPA) – eTMF & Registry Support
    Location: Hyderabad, India
    Travel: As per business needs
    Job Type: Permanent, Full-time

    About Sanofi Business Operations (SBO)

    Sanofi Business Operations (SBO) is an internal resource organization that centralizes processes across various functions such as Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital. SBO aims to support global business functions with tactical deliveries to Medical, HEVA, and Commercial teams at Sanofi, helping streamline activities and reduce reliance on external service providers.

    Main Responsibilities

    As a Clinical Project Assistant (CPA), you will provide administrative and operational support throughout the clinical trial process, particularly focusing on the electronic Trial Master File (eTMF) and registry studies. Your key duties will include:

    Document & eTMF Management:

    • Set up and maintain eTMF systems for registry studies, ensuring compliance with protocols, GCP guidelines, and company SOPs.
    • Oversee TMF archiving, including the preparation, collection, reconciliation, and filing of relevant documents.
    • Manage the uploading of documents for all sites, ensuring primary Quality Control (QC) checks are conducted.
    • Track the volume of documents uploaded, ensuring proper classification and organization in the eTMF system.
    • Ensure the study team compliance for inspection-readiness at all times, guaranteeing documents are properly filed and retrievable during audits.

    Project Coordination & Administrative Support:

    • Coordinate project schedules, ensuring updates on key milestones are delivered to the registry team.
    • Provide administrative support with project management activities and budget tracking as needed.
    • Support the onboarding of new project team members and assist with system access coordination.
    • Prepare and maintain project correspondence, including meeting minutes, for the project team and/or customers.
    • Assist with core file reviews and support audits as necessary.
    • Oversee e-Training tracking and ensure compliance throughout the project.

    Stakeholder Interaction & Collaboration:

    • Collaborate with internal stakeholders, including Clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), and site staff to ensure the timely completion of administrative tasks.
    • Build and maintain effective working relationships with site teams and stakeholders.
    • Cooperate across functions and contribute to improving registry study efficiency and execution.

    About You

    Experience & Skills:

    • 3+ years of experience in clinical research and development, particularly in eTMF document management.
    • Familiarity with ICH GCP guidelines and clinical trial methodologies.
    • Proven ability to handle confidential data and information appropriately.
    • Strong attention to detail and a methodical approach to work.
    • Experience working with emerging technologies and mobility applications.

    Soft Skills:

    • Strong written and verbal communication skills.
    • Excellent relationship management skills with sites, study teams, and stakeholders.
    • Cross-functional collaboration experience, working effectively with various teams and departments.

    Technical Skills:

    • Proficiency with Microsoft Office tools.
    • Experience in eTMF management and document control for clinical trials.
    • Understanding of local regulatory requirements and ICH-GCP principles.

    Education:

    • Bachelor’s degree in life sciences or a related field.

    Languages:

    • High proficiency in written and spoken English.

    Why Sanofi?

    At Sanofi, we believe that progress doesn’t happen without people. We are committed to creating better medications, better outcomes, and extraordinary science. Our diverse and inclusive work environment fosters collaboration and offers opportunities for growth and development.

    Equal Opportunity Employer:
    Sanofi is committed to providing equal opportunities to all candidates regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

    Pursue Progress. Discover Extraordinary.
    Join us in contributing to making miracles happen and discover extraordinary potential in healthcare together.

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