Associate Project Manager – Externally Sponsored Research

2+ years

Not Disclosed

Hyderabad

10 Nov. 7, 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

Associate Project Manager – Externally Sponsored Research (ESR)

Location: Hyderabad, India
Job Type: Full-Time, Permanent
Travel: As per business need

About Us

Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in Hyderabad, India, designed to centralize and optimize processes to support Sanofi’s global functions, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital. Our team plays a strategic role in delivering tactical solutions and operational excellence across Medical, HEVA, and Commercial functions globally.

We are looking for a dynamic Associate Project Manager – Externally Sponsored Research (ESR) to join our team. In this role, you will oversee the operational activities of externally sponsored research, ensuring timely and compliant review, start-up, execution, and closeout of studies supported by Sanofi. You will work closely with cross-functional teams to ensure smooth execution and delivery of research programs.

Main Responsibilities

As an Associate Project Manager – ESR, you will be responsible for managing the operational aspects of Externally Sponsored Research (ESR), including Investigator-Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC). Your key tasks will include:

Study Operational Oversight

Manage ESR Lifecycle: Oversee the full ESR process from initial proposal submission through study closeout, ensuring timely and compliant execution of studies.
Collaboration with Senior Managers: Work with senior managers to ensure compliant and efficient reviews of ESR proposals, protocols, and amendments.
Project Tracking: Ensure tracking of key research milestones, payment management, and proper documentation throughout the ESR lifecycle.

Process and Compliance Management

Process Execution: Ensure all ESR-related activities comply with Sanofi SOPs, policies, and regulatory requirements. Ensure smooth integration and execution of research agreements, product supply, purchase orders, and other deliverables.
Audit Readiness: Contribute to audit readiness and provide rapid responses to audit inquiries, ensuring ESR activities align with industry standards (GCP, ICH, OIG, PhRMA Code, etc.).
Metrics and Reporting: Support the development of key performance indicators (KPIs) and business analytics to measure ESR program progress and inform investment decisions.

Stakeholder Management

Cross-Functional Collaboration: Work closely with R&D, Product Supply, Clinical Operations, and other internal stakeholders to ensure effective collaboration and alignment across global ESR teams.
Training & Support: Ensure ESR teams and stakeholders are trained on the ESR system of record and relevant tools. Oversee the dissemination of safety updates and Dear Investigator Letters (DILs).

ESR System Oversight

System Management: Ensure the integrity and compliance of the ESR system of record, including enforcing standards, controls, and permissions. Collaborate with system vendors for issue resolution and enhancements.

About You

We are looking for a motivated professional with clinical research and project management expertise. If you have a strong track record in clinical trial management and a passion for driving efficiency in research operations, this could be the perfect opportunity for you.

Experience

6+ years of experience in clinical research and clinical trial project management, preferably in a pharmaceutical or CRO environment.
Project Management Certification is a plus.
Strong quantitative, analytical, and problem-solving skills with a track record of driving process efficiency.

Skills & Competencies

Cross-functional Collaboration: Proven experience working with multiple teams to ensure timely and efficient execution of research projects.
Strong Communication: Excellent written and oral communication skills, with the ability to engage stakeholders at all levels.
Regulatory Knowledge: Knowledge of Medical Investigator Sponsored Studies (ISS) program requirements and relevant regulations (e.g., GCP, ICH, OIG, PhRMA Code).
Analytical Skills: Ability to analyze complex data, develop metrics, and provide actionable insights to internal stakeholders.
Self-starter & Adaptability: Proven ability to work independently, take initiative, and drive projects to completion while embracing innovation and change.

Education

Degree in Medical, Pharma, Life Sciences, or a related field with substantial project management or clinical trials and drug development experience.

Languages

Fluent in English (spoken and written).

Why Choose Sanofi?

At Sanofi, we are committed to progress—in science, medicine, and the people who help bring it all to life. By joining our team, you’ll work alongside passionate and diverse individuals who are all focused on making a meaningful impact in global healthcare.

What We Offer:

Career Growth: Endless opportunities to grow your talent and career within a dynamic, global company.
Competitive Compensation: A comprehensive rewards package that recognizes your contribution.
Global Impact: Be part of a team that is shaping the future of healthcare.

Join us on our mission to pursue progress and discover extraordinary!

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Associate Project Manager – Externally Sponsored Research

Job Description

Associate Project Manager – Externally Sponsored Research (ESR)

About Us

Main Responsibilities

Study Operational Oversight

Process and Compliance Management

Stakeholder Management

ESR System Oversight

About You

Experience

Skills & Competencies

Education

Languages

Why Choose Sanofi?

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