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    Associate Project Manager – Registry Study Management

    Sanofi
    5-7 years
    Not Disclosed
    Bogota Hyderabad India
    10 Feb. 11, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: Associate Project Manager – Registry Study Management
    Reports to: Project Lead – ESR and Grants
    Location: Hyderabad/Bogota
    Job Type: Permanent, Full-time
    % of Travel Expected: Travel required as per business need

    About Sanofi Business Operations (SBO):

    Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India, centralizing processes and activities to support various business units such as Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. SBO works as a strategic partner, reducing reliance on external service providers while fostering internal expertise.

    Job Overview:

    The Associate Project Manager – Registry Study Management will support the operational execution of global rare disease registries. This role ensures the smooth running of registry studies by managing timelines, stakeholder communications, risk management, budget tracking, and regulatory compliance.

    Key Responsibilities:

    Project Planning and Coordination:

    • Review project updates, timelines, milestones, and resource allocation regularly.
    • Coordinate with international/external teams and CROs to ensure alignment and collaboration.
    • Organize meetings, take meeting minutes, and assist with administrative tasks.
    • Develop dashboards and follow up on key metrics.

    Stakeholder Management:

    • Regular communication with internal/external stakeholders (cross-functional teams, investigators, regulatory bodies) to update on project progress, changes, and any issues.
    • Ensure timely dissemination of project information.

    Regulatory Compliance:

    • Ensure all projects adhere to relevant regulatory requirements and guidelines.
    • Manage documentation and reporting to maintain compliance.

    Risk Management:

    • Identify potential project risks and collaborate on mitigation strategies.
    • Monitor risks and resolve issues as they arise to minimize project impact.
    • Track risk closures and ensure proper documentation.

    Quality Assurance:

    • Implement quality control measures to maintain high standards in project operations.
    • Support audits/inspections and ensure compliance with project standards.

    Budget Management:

    • Monitor site payments, reconciliation, and forecasting.
    • Track project expenses and ensure adherence to budget.
    • Develop and report on budget-related metrics.

    Reporting and Documentation:

    • Maintain detailed records of project activities and outcomes.
    • Prepare and present regular reports on project status and performance.
    • Track key performance indicators (KPIs) for the project.

    Miscellaneous Administrative Tasks:

    • Perform ad-hoc assignments as needed.

    Process Management:

    • Oversee assigned registry studies, ensuring clear understanding and alignment with registry study strategy.
    • Coordinate registry data analysis requirements and site payments.
    • Ensure execution of registry studies meets quality, timeline, and budget expectations.
    • Provide oversight for audits and inspections.

    Stakeholder Engagement:

    • Collaborate effectively with internal and external stakeholders to support the registry function’s goals.
    • Ensure strong communication and alignment with stakeholders to improve registry program efficiency.

    About You:

    Experience:

    • 5+ years of experience in project management, including 3+ years in Clinical Research & Development or Real-World Evidence (RWE) management.
    • Strong quantitative, analytical, and problem-solving skills.
    • Proven experience in cross-functional collaboration.
    • Experience in working in global projects and matrix environments.
    • Project Management certification (preferred).

    Soft Skills:

    • Excellent written and oral communication skills.
    • Strong organizational, project management, and time management skills.
    • Ability to manage and negotiate with stakeholders at all levels.
    • Proactive, results-oriented, and capable of handling emergent needs.

    Technical Skills:

    • Knowledge of clinical studies, GCP, ICH standards, and regulatory requirements.
    • Familiarity with project management tools, such as Smart Sheets (preferred).
    • Ability to manage project metrics, KPIs, and financial reporting.

    Education:

    • Degree in a Scientific discipline, Pharmacy, or related Life Science field, with substantial experience in project management or clinical trials.

    Languages:

    • High proficiency in written and spoken English.

    Why Join Us?

    • Career Growth: Sanofi offers ample opportunities for personal and professional growth.
    • Diversity & Inclusion: We are committed to providing equal opportunities to all.
    • Comprehensive Benefits: Competitive benefits to support work-life balance and overall well-being.

    How to Apply:

    If you have the required experience and are passionate about contributing to global registry studies, apply today to join our dedicated team in delivering better health outcomes worldwide.

     

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