Central Clinical Research Associate

Sanofi; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Sanofi Business Operations in India is seeking a clinical research professional with 5+ years of experience to support study start-up, site qualification, and regulatory submissions. You will coordinate with Registries, EC/IRB, and Data Management to ensure timely and compliant trial conduct across sites.

The role emphasizes quality, safety reporting, and collaboration across global teams within a matrix environment. Strong writing and communication skills are essential.

Qualifications

• 5+ years of clinical research and development experience, including trial monitoring.
• Experience with global projects and matrix environments is a plus.
• Proficient in technical writing and regulatory document preparation.

Responsibilities

• Participate in feasibility and site selection activities with Registries Team.
• Assist in collection and review of HA/RA submission documents and EC/IRB materials.
• Prepare EC cover letters and ensure follow-up with EC as needed.
• Support Insurance Certificate applications and site document collection for budgets.
• Assist with TMF/eTMF processes from setup to archiving across sites.
• Coordinate data collection, site monitoring liaison, and data quality checks.
• Liaise with vendors for startup and onsite monitoring activities.
• Ensure safety reporting processes and CAPA-driven quality improvements.

Skills

Attention to Detail

Problem-Solving

Project Management

Technical Writing

Communication

Global projects experience

Education

Degree in pharma/scientific discipline

Tools

eTMF systems

MS Office

Job description

About the job

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. Feasibility Activities:
   • Involvement in the site selection process together with the Registries Team.
2. Study Start-up Activities:
   • Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB)
   • Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.
   • Prepare EC cover letter and any additional materials required (if applicable)
   • Ensure appropriate follow-up with EC for additional questions and to inform sites. (if applicable)
   • Prepare the Insurance Certificate application when applicable.
   • Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites.
   • Ensure Inform Consent Form (ICF) customization based on country requirements, incorporate site details, and perform appropriate quality review and version tracking per site. (if applicable)
   • Assist with the upload & file of Study Start-up documentation into the eTMF.
   • Ensure that all parties are informed about project progress, changes, and any issues that arise.
3. Management of the Site Data:
   • Reviews study data from various sources remotely.
   • Follow up of trial progress and quality control of data (source document check).
   • Review of electronic Case Report Form (eCRF) completeness and query resolution by the sites.
   • Escalate issue(s), when necessary.
   • To maintain contact with Data Management group.
   • To coordinate international data collection projects.
4. Site Management:
   • Recruitment Follow up on patient enrolment and patient status.
   • Site facility & staff: Assure that site facilities are adequate, according to protocol needs, local regulations, GCP and applicable SOPs (global/local).
   • Assure site staff training and access to different systems.
   • Develops collaborative relationships with investigational sites and other stakeholders as applicable.
   • Liaise with Vendor for different activities (startup, onsite monitoring).
5. Safety & Quality:
   • Assure adequate safety reporting process of the site, and that site is submitting and/or undefined Quality control of study conduction at site level - with "Audit/inspection readiness" mindset.
   • Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary.
6. Study administration:
   • To maintain all the tables, trackers and databases updated to follow the study progress undefined
   • To know and use all the tools needed.
   • Participates in the investigator payment process, if applicable
   • To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in collecting site documents required.

About you

5+ years of experience in Clinical research & development including clinical trial monitoring experiences. Rare diseases or observational studies, real world evidence experience will be a plus. Attention to Detail: Critical for monitoring trial data and ensuring accuracy. Problem-Solving: Ability to address and resolve issues that arise during trials. Project Management: Skills in managing timelines, budgets, and resources. Technical Writing: Proficiency in writing reports, protocols, and regulatory documents. Experience in working in global projects and international matrix environment.

Soft skills

• Communication: Excellent written and oral communication skills to interact with various stakeholders.
• Adaptability: Ability to adapt to changing requirements and environments3.Interpersonal Skills: Building and maintaining positive relationships with stakeholders3.Time Management: Efficiently managing time and prioritizing tasks. Ethical Judgment: Strong sense of ethics and integrity in conducting clinical research.

Technical skills

• Good Clinical Practice (GCP): Understanding and adherence to GCP guidelines.
• Regulatory Requirements: Knowledge of regulatory requirements and guidelines (FDA, EMA, etc.).
• Clinical Trial Processes: Familiarity with clinical trial phases, protocols, and methodologies.
• Data Management: Skills in data collection, analysis, and reporting.
• Medical Terminology: Proficiency in medical terminology and procedures.
• Competent with Microsoft Office products.

Education

Degree in a Pharma/scientific discipline or a related Life science degree

Languages

High Proficiency in written and spoken English.

Diversity, Equity, and Inclusion

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!

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!

About Sanofi

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.

Mission Statement

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.

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.