Associate Manager - Externally Sponsored Research

Sanofi India Ltd; Hyderabad; Vor Ort; INR 1.500.000 - 2.100.000; Vollzeit

Zusammenfassung

Sanofi India Ltd is seeking an Associate Manager Externally Sponsored Research to lead study operations across ESR programs. You will manage proposals, budgeting, supplier coordination, and timely execution in line with global standards.

You will collaborate with R&D, SRC teams, and external sponsors to ensure compliant, efficient reviews of protocols, keep data integrity in ESR systems, and drive performance analytics for strategic decisions.

Qualifikationen

• 6+ years of experience in clinical research and development including clinical trial project management.
• Project management certification preferred.
• Degree in Medical/Pharma/scientific discipline.

Aufgaben

• Oversee ESR study operations from proposal submission to closeout.
• Ensure ESR activities comply with Sanofi SOPs, policies, and local laws.
• Coordinate cross-functional delivery of research agreements and product supply.
• Support SRC/ESR reviews of concepts, study outlines, and protocols.
• Develop and report metrics, KPIs, and investment decisions.
• Maintain ESR system of record and ensure data integrity.

Kenntnisse

Clinical research

Clinical trial management

Project management

Ausbildung

Medical/Pharma/scientific degree

Jobbeschreibung

Associate Manager Externally Sponsored Research

Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool.

Main Responsibilities

1. Manages the overall study operational activities for all ESRs from initial proposal submission to study closeout including (but not limited to) SRC management, tracking ESR performance, supply management, contracting, obtaining regulatory documentation and cross-reference letters, transfer of value reporting, tracking payments, and overall ESR program reporting.
2. Executes all ESR process-related activities compliantly per Sanofi SOPs, policies & procedures, and local laws & regulations. Contributes to program audit readiness and provides accurate and rapid responses to audit inquiries.
3. Collaborates cross-functionally to ensure efficient and timely delivery of research agreements, product supply, purchase orders and other deliverables.
4. Collaborates closely with Sr. Mangers to provide necessary information and support to SRC and ensure compliant, timely, efficient reviews of concepts, study outlines, protocols, and protocol amendments.
5. Supports the development of metrics, KPI’s and other business analytics to measure progress and inform investment decisions; ensures study updates are collected, documented, tracked, and communicated to stakeholders.
6. Oversees ESR system of record; maintains data integrity by enforcing standards, controls & permissions. Works with system vendor and Systems & Process Ops team on issue resolution and enhancements.
7. Collaborates with R&D and Local Product Supply teams to ensure product demand forecasts are maintained and updated to reflect current needs for adequate supply of active studies.
8. Collaborates and provides information for CMO reporting and cross-GBU initiatives related to ESR.
9. Supports dissemination of safety updates and Dear Investigator Letters (DILs).
10. Ensures stakeholders are trained and have access to ESR system of record and other ESR related tools, and manages the team.

People

(1) Seek alignment with team members and key stakeholders to ensure integration and appropriate prioritization of ESR activities, and compliance with approved processes; (2) Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the primary objective of adding value to the business

Process

(1) Develop and maintain of robust project timelines for assigned ESR programs by demonstrating a clear understanding of the ESR program strategy, detailed ESR project activities, and associated budget; (2) Ensure an accurate and updated ESR system as per SOP and process; (3) Manage ESR access for the ESR resources (e.g., local and global External Sponsored Research reviewers and other resources) 4) Perform initial Quality Check of External Sponsored Researches submissions (Study Proposal, & Protocol); (5) Manage the workflow in iEnvision (i.e., advance the External Sponsored Researches to the various review stages through protocol approval); (6) Provide oversight on the execution of all External Sponsored Researches; (7) Responsible for coordination for product supply/tracking/collection of related documents; (8) Responsible for SRC coordination for ESR proposal/protocol reviews; (9) In coordination with the Sanofi senior project manager-ESR Ops, oversee the ESR budget, manage payment/invoice tracking; timely agreement finalization (10) Coordinate for External Sponsored Research audit; (11) Manage DIL SharePoint and related task ; (12) Provide metrics, KPI’s and other business analytics to the internal stake holders as per the frequency defined (13) QC of ESR documents and archival of ESR as per process

Stakeholder

(1) Commit to Customers - Understand, meet, and excel internal and external customer expectations to create positive impact through the evolution of the ESR Operations function. (2 Cooperate Transversally - collaborate effectively with peers, stakeholders, and partners across the organization to positively impact ESR program efficiency and execution.

About you

Experience

6+ years of experience in Clinical research & development including clinical trial project management experiences.

Project management certification preferred.

Soft skills

Excellent written and oral communication skills. Excellent organizational and project management skills, and ability to meet deadlines and stakeholder management.

Technical skills

Knowledge of Medical Investigator Sponsored Studies program requirements and understanding of the external environment and regulations that impact the conduct of such programs, including GCP, ICH standards, OIG, PhRMA code, etc. preferred. Ability to think broadly and long-term to drive excellence in execution and timely decision making based on information available to support compliant and efficient delivery of study milestones. Take responsibility for self-development to improve performance and positive impact to the organization along with driving individual career progress. Embrace change and innovation by supporting the evolution of the ESR Operations function, driving improved effectiveness.

Education

Degree in a Medical/Pharma/scientific discipline or a related Life science degree, with substantial project management or clinical trials and drug development experience.

Languages

High Proficiency in written and spoken English Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Equal opportunity

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com ! Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Experience Level Mid Level