Associate Manager SRC Governance

Sanofi; Hyderabad; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Sanofi India’s SBO group seeks an experienced Clinical Research Project Manager to lead governance for ESRs, Phase 1 studies, and MRPTC, coordinating with local medical teams and global partners. The role focuses on organizing review meetings, capturing decisions, and ensuring alignment with Sanofi policies.

You will prepare audit-related documentation, manage temporary staff, and participate in ad-hoc meetings to support timely, high-quality proposals and decisions.

Qualifications

• Experience: 6+ years in Pharmaceutical or medical industry with Clinical Research Project Management.
• Soft skills: Leadership; Strategic thinking and decision making; Stakeholder management; Project management; Commitment to customers; Ability to work independently and in a team.
• Education: Bachelor/Master’s degree in life sciences.

Responsibilities

• Set up governance for ESRs, Phase 1 studies, and MRPTC per operating model.
• Coordinate with local medical teams and global medical program, HEVA, and partners to review and approve meetings.
• Capture comments and circulate decisions from meetings; prepare documentation to support audit-related activities.
• Manage temporary help as needed and participate in ad-hoc meetings as required.

Skills

Leadership

Strategic thinking

Stakeholder management

Project management

Microsoft Office

Education

Bachelor/Master’s degree in life sciences

Tools

Microsoft Office

Job description

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 (SBO) is built to reduce reliance on external services providers and facilitate the development of internal expertise. The Sanofi Business Operations (SBO) will leverage untapped combination of talent pool.

Main responsibilities:

Committee review Governance team support to set up governance to review meetings for all 4 committee reviews for ESRs, Phase 1 studies, Global Health Studies and MRPTC as per the established operating model. Study Review Committee Primary responsibility is to Set up governance to review approval meetings for all 4 committee reviews - Company Sponsored Studies & Externally Sponsored Collaborations (CSS & ESC), ISS, Global Health Studies as per the established operating model. Identify the stakeholders required for the review approval meeting and organize stakeholder alignment pre-SRC meeting to ensure high quality, mature proposals are brought to the SRC and for improved meeting efficiency & decision making. Capture the comments and responses in the Action Register. Maintain and distribute documents along with Action register to the SRC reviewers and moderate the SRC meeting to discuss any unresolved issues in the Action Register, record the decision. Capture and circulate the decisions from the meeting. Prepare and provide documentation to support audit-related activities to ensure compliance with Sanofi policies & procedures at the local, regional, and global level. Manage temporary help as needed and participates in the other ad-hoc meetings as required Primary point of contact for study requestor i.e., local medical teams and global medical program, Global HEVA Business partners to manage SRC review program, process inquiries etc. Medico-Regulatory Pharmacovigilance Transversal Committee (MRPTC) Lead the conduct of the MRPTC including the preparatory meetings, minutes of meeting, follow-up, and coordination with local, regional, and global stakeholders. Collaborate with the stakeholders to organize MRPTC review approval meetings as per the established operating model and capture the decisions from the meeting Identify the stakeholders required for the review approval meeting and organize stakeholder alignment pre-MRPTC meeting to ensure high quality, mature proposals are brought to the MRPTC and for improved meeting efficiency & decision making. Capture the comments and responses and circulate the decisions from the meeting. Phase I SRC Set up governance to review approval meetings for all Phase 1 studies as per the established operating model. Ensure the key interface between the cross-functional local and global representatives: Local medical, global medical portfolio development phase I, local/global BEQ coordinators and CSO. Ensure planned timelines are met by successful planning and execution. Close follow up on and report of risks, challenges, and mitigation plans. Capture the comments and responses and circulate the decisions from the meeting.

People:

(1) Maintain effective relationship with internal Sanofi stakeholders (2) Regular connects with Sanofi stakeholders and relevant teams and manages the team.

Performance:

(1) Effective and efficient management of assigned studies to complete on time

Process:

Adherence to timeline and quality target

Stakeholders:

(1) Identify and Align with key stakeholders 2) Liaise with relevant stakeholder for assigned task

About you

Experience: 6 + years’ experience in Pharmaceutical or medical industry and relevant experience in Clinical Research Project Management; Thorough Clinical research knowledge. Soft skills: Leadership; Strategic thinking and decision making; Stakeholder management; Project management; Commit to Customers; Ability to work independently and within a team environment Technical skills: Highly proficient with Microsoft Office (Outlook, Excel, Word, PowerPoint). Education: Bachelor/ Master’s degree required – life sciences Languages: Excellent English language knowledge – written and spoken

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! We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.