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    Clinical Project Assistant

    Sanofi
    3+ years
    Not Disclosed
    Hyderabad
    10 Dec. 3, 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

    About the Job

    Our Team:
    Sanofi Business Operations (SBO) is a dedicated internal resource organization in India, established to centralize processes and activities supporting Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data, and Digital functions. SBO aims to be a strategic partner, providing efficient tactical support to Sanofi's global Medical, HEVA, and Commercial organizations. By reducing reliance on external providers and building internal expertise, SBO harnesses a highly skilled talent pool to drive operational excellence.

    Main Responsibilities:
    As a Clinical Project Assistant (CPA), your role will include:

    • eTMF Management: Assist the Registries team in setting up and managing the electronic Trial Master File (eTMF), ensuring compliance with protocols, Good Clinical Practices (GCP), and company SOPs.
    • Document Archiving: Prepare, reconcile, and file documents for the TMF archiving process.
    • Quality Control: Upload and perform quality checks on documents for existing and new sites.
    • Project Coordination: Support project management activities, update schedules, and track milestones in collaboration with the Registries team.
    • Budget and Payments: Monitor project budgets and assist with site payment processes as required.
    • Documentation and Audits: Maintain registry materials, coordinate file reviews, prepare meeting minutes, and support audits.
    • Training and Onboarding: Track project-specific e-training compliance and onboard new team members.
    • SharePoint Maintenance: Update and manage Registries SharePoint.
    • Administrative Support: Handle miscellaneous tasks to ensure smooth project execution.

    Key Interactions:

    • Collaborate with study teams, including Clinical Project Leaders (CPLs) and Clinical Research Associates (CRAs), ensuring timely completion of administrative tasks.
    • Liaise with site staff as needed to support clinical project operations.

    Performance and Process Excellence:

    • Maintain registry study documents and conduct routine QC checks.
    • Ensure eTMF systems and local trial master files (paper and electronic) are always audit-ready, adhering to SOPs and regulatory guidelines.
    • Oversee the classification and organization of eTMF documents for streamlined access during audits and inspections.

    Stakeholder Collaboration:

    • Customer Focus: Understand and exceed internal and external stakeholder expectations to enhance registry study functions.
    • Cross-Functional Teamwork: Work collaboratively with peers, stakeholders, and partners across Sanofi to improve study efficiency and execution.

    About You:

    Experience:

    • 3+ years in clinical research and development, with hands-on experience in eTMF document management.
    • Strong understanding of ICH GCP guidelines and clinical trial methodologies.

    Soft Skills:

    • Exceptional written and verbal communication.
    • Proficient in eTMF management with a keen attention to detail.
    • Skilled in maintaining confidentiality and building effective relationships with sites and study teams.

    Technical Skills:

    • Organized, methodical, and adept at prioritizing tasks.
    • Familiarity with ICH-GCP principles and local regulatory requirements.
    • Proficient with Microsoft Office and comfortable with emerging technologies.

    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 in the power of progress—through better medications, outcomes, and science. But none of it happens without people. People from diverse backgrounds, in various locations, and different roles, united by the desire to make miracles happen.

    Our Commitment to Diversity:
    Sanofi is an equal opportunity employer. We celebrate diversity and are committed to providing an inclusive environment for all employees.

    Discover more about our Diversity, Equity, and Inclusion initiatives and what a day at Sanofi looks like at sanofi.com.

    Let’s pursue progress and discover extraordinary together.

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