Associate Manager, Externally Sponsored Research
By Admin · Research & Development (Lab & Science)
ROLE OVERVIEW
Sanofi Business Operations (SBO) in Hyderabad seeks an Associate Manager, Externally Sponsored Research (ESR) to oversee investigator-sponsored studies and externally sponsored collaborations from concept submission through closeout. This role sits at the intersection of clinical research, medical governance, and operational excellence, ensuring that unsolicited research support requests are routed for scientific review and managed in compliance with Sanofi SOPs, ICH-GCP, and local regulations. It is critical to Sanofi's Specialty Care, Vaccines, General Medicines, and R&D pipelines because ESRs generate real-world evidence and expand research partnerships. The position offers deep exposure to global stakeholders, SRC coordination, study start-up, product supply, contracting, and audit readiness. For professionals with clinical trial project management experience, it is a compelling opportunity to build specialized expertise in externally sponsored research operations while contributing to compliant, timely delivery of studies that inform medical and commercial strategy.
ROLE DEFINITION & RESPONSIBILITIES
- •Manage end-to-end ESR operations from initial proposal intake through scientific review, contracting, study start-up, execution, closeout, and archival.
- •Coordinate Scientific Review Committee (SRC) reviews, prepare dossiers, track protocol amendments, and ensure timely compliant approvals for approved ESRs.
- •Oversee ESR system of record and iEnvision workflow, performing quality checks, maintaining data integrity, access permissions, and audit-ready documentation.
- •Collaborate with R&D, Local Product Supply, legal, finance, and medical teams to secure research agreements, product supply, purchase orders, and payments.
- •Track study milestones, budget, invoices, transfer of value, KPIs, and program metrics; report progress to internal stakeholders and leadership.
- •Support audit readiness, safety updates, Dear Investigator Letters (DILs), and responses to inquiries from auditors, regulators, and cross-functional partners.
- •Train stakeholders on ESR tools and processes, manage team activities, and drive process improvements, KPI development, and cross-GBU initiatives.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Degree in Medical, Pharma, scientific, or life sciences discipline (MBBS, MD, B.Pharm, M.Pharm, PharmD, MSc, or equivalent).
- Minimum 6+ years in clinical research and development, including clinical trial project management and study oversight.
- Proven experience with investigator-sponsored studies, externally sponsored research, or medical affairs research programs.
- Strong knowledge of ICH-GCP, applicable regulations, OIG, PhRMA code, and clinical trial documentation requirements.
- Project management certification (PMP, PRINCE2, or equivalent) preferred; demonstrated budget and timeline ownership.
- Excellent written and spoken English for global stakeholder communication, SOP authorship, and audit responses.
- Experience managing cross-functional teams, vendors, and system access within a matrixed pharmaceutical environment.
PREFERRED QUALIFICATIONS
- •PMP or PRINCE2 Certification
- •Experience with Veeva Vault or similar eTMF
- •Real-World Evidence (RWE) and HEVA exposure
- •Contracting and Product Supply Coordination
- •KPI Dashboard and Business Analytics
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Sanofi is a global biopharmaceutical company dedicated to human health. It researches, develops, manufactures, and markets innovative therapeutic solutions with a focus on specialty care, vaccines, general medicines, and consumer healthcare products. The company aims to prevent and treat a wide range of diseases worldwide.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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