Hiring Central Clinical Research Associate at Sanofi

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life.

Post : Central Clinical Research Associate

Job Description
1. Feasibility Activities :
o Involvement in the site selection process together with the Registries Team.
2. Study Start-up Activities :
• Assist in collecting site documents for submission to the Health Authority (HA)/Regulatory Authority (RA) and Ethics Committees (EC)/Institutional Review Board (IRB).
• Review and ensure the quality of site and study documents prior to submission to central, local, hospital committees, and HA/RA.
• Prepare EC cover letters and any additional required materials, if applicable.
• Follow up with EC regarding additional queries and communicate updates to sites, if applicable.
• Prepare the Insurance Certificate application, when applicable.
• Support the Site Contract process, including the collection of required site documents, budget negotiations, and final agreement with sites.
• Ensure customization of the Informed Consent Form (ICF) based on country-specific requirements, incorporating site details, and conducting quality reviews and version tracking per site, if applicable.
• Assist with uploading and filing Study Start-up documentation into the electronic Trial Master File (eTMF).
• Ensure all stakeholders are kept informed about project Progress, changes, and any arising issues.
Site Monitoring :
• Off-Site Visits
o Perform remote site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
o Plan, prepare, conduct, report and follow up site (and satellite sites) remote visits - Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs.
• Onsite (where local hub affiliates are located)
o Perform onsite site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
o Plan, prepare, conduct, report and follow up Onsite site (and satellite sites) visits - Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs.
o Perform remote site management and related activities for assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
o Management of the Site Data :
o Reviews study data from various sources remotely.
o 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 :
o Recruitment Follow up on patient enrolment and patient status.
o 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.
o Develops collaborative relationships with investigational sites and other stakeholders as applicable.
o 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
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• 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
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• 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.
• Study Meetings: To participate with the rest of the study team in local and international investigators and/or monitors meetings (where required), study/operational meetings, quality audits and inspections for the registries, study set-up meeting and trainings.

Candidate Profile
• Experience : 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 undefined·
• Languages : High Proficiency in written and spoken English. Pursue progress, discover Extraordinary.

Additional Information
Experience : 5+ years
Qualification : Degree in a Pharma/scientific
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : CR
End Date : 30th November 2026