Associate Project Manager – Externally Sponsored Research

Sanofi

2+ years

Not Disclosed

Hyderabad

10 Nov. 15, 2024

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 – Externally Sponsored Research
Hiring Manager: Project Lead – ESR and Grants
Location: Hyderabad
% of Travel: As per business need
Job Type: Permanent, Full-time

About the Job

Our Team:
Sanofi Business Operations (SBO) is an internal organization based in India that centralizes processes and activities to support various functions, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. Our goal is to reduce reliance on external service providers and develop internal expertise while leveraging a unique talent pool to support global initiatives.

Key Responsibilities:

As an Associate Project Manager – Externally Sponsored Research (ESR), you will oversee the operational management of unsolicited research support requests, ensuring compliance and efficiency throughout the process, from initial proposal submission to study closeout. Your main duties include:

Study Management: Oversee ESR activities from submission to closeout, including SRC management, tracking study performance, supply management, contracting, regulatory documentation, and financial reporting.
Process Compliance: Execute ESR-related activities in compliance with Sanofi’s SOPs, policies, and local regulations.
Cross-Functional Collaboration: Work with internal teams to ensure smooth delivery of research agreements, product supply, and related deliverables.
Support to Senior Managers: Provide necessary data and support to SRC for timely reviews of study proposals, protocols, and amendments.
Metrics and Reporting: Develop and track metrics, KPIs, and other business analytics to measure progress and inform decisions.
System Oversight: Manage ESR system data integrity, troubleshooting issues, and ensuring efficient processes.
Forecasting and Product Supply: Collaborate with R&D and Local Product Supply teams to maintain accurate product demand forecasts.
Stakeholder Communication: Disseminate safety updates and manage internal and external communications efficiently.

Key Responsibilities (Continued):

Manage product supply tracking, agreement finalization, budget oversight, and payment tracking.
Coordinate external research audits and ensure accurate documentation of ESR activities.
Maintain ESR documents and support quality control and archival processes.
Lead and manage a team, aligning efforts with ESR strategy and objectives.

About You

Experience: 6+ years in clinical research and project management, particularly in clinical trials and drug development. Project management certification preferred.
Skills: Strong analytical, problem-solving, and cross-functional collaboration skills. Ability to manage multiple tasks and meet deadlines.
Technical Knowledge: Familiarity with Investigator-Sponsored Studies program requirements, GCP, ICH standards, and regulatory frameworks.
Soft Skills: Excellent communication and organizational skills, with an ability to drive efficiencies in processes and stakeholder management.
Education: Degree in a Medical, Pharma, or Life Science discipline with substantial project management experience.
Language: High proficiency in written and spoken English.

Why Sanofi?

At Sanofi, we believe in progress. We strive for better medications, better outcomes, and better science, driven by a team of diverse individuals united by a common mission to make miracles happen. We provide equal opportunities for all, ensuring diversity and inclusion in everything we do. Let’s pursue progress and discover extraordinary together!

Watch our ALL IN video and explore our Diversity, Equity, and Inclusion actions at sanofi.com.

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Associate Project Manager – Externally Sponsored Research

Job Description

About the Job

Key Responsibilities:

Key Responsibilities (Continued):

About You

Why Sanofi?

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