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;;RD, 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:

The Associate Manager ;Externally Sponsored Research is responsible for operational oversight of unsolicited research support requests submitted through the company web portal, to ensure they are appropriately routed for scientific review. This position will ensure timely and compliant study review, start-up, execution, completion, and tracking of key research milestones as per research agreement, for ESRs approved by the Scientific Review Committee (SRC). Externally Sponsored Research (ESR) refers to Investigator-Sponsored Study (ISS) and Externally Sponsored Collaboration (ESC) where Sanofi provides financial and non-financial support to the external sponsor.;;

Below are the key responsibilities including

• 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 RD 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. Strong quantitative, analytical (technical and business) and problem-solving skills is a must. Excellent cross-functional collaboration skill and experience required. Proven self-starter with experience driving efficiency in processes highly desirable.


• ;;;;;;;;;;;;; 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