Sanofi Hiring Central CRA (Clinical Research Associate) – Registries

Sanofi is hiring for the role of Central CRA (Clinical Research Associate) to support registries in Hyderabad, India. This is a full-time, permanent role that requires travel as per business needs. Join Sanofi Business Operations (SBO), a dynamic internal organization designed to centralize and streamline processes across Specialty Care, Vaccines, General Medicines, and more.

Key Highlights

Job Title

Central CRA (Clinical Research Associate) – Registries

Location

Hyderabad, India

Job Type

Full-time | Permanent

Hiring Manager

Project Lead – ESR and Grants

Application Deadline

• Posted on: January 21, 2025
• Closing Date: February 22, 2025

Travel Requirement

Travel as per business needs.

Responsibilities

Feasibility Activities

• Participate in site selection processes in collaboration with the Registries Team.

Study Start-Up

• Collect, review, and submit site documents for regulatory and ethical approvals.
• Customize and review Informed Consent Forms (ICF) based on local and country-specific requirements.
• Assist with insurance certificate applications and the study start-up documentation process in the electronic Trial Master File (eTMF).

Site Monitoring

• Conduct both remote and on-site visits for site selection, initiation, routine monitoring, and close-out activities.
• Monitor trial progress, ensure data quality, and resolve queries promptly.

Data and Site Management

• Collaborate with investigational sites for data review and recruitment progress.
• Ensure compliance with Good Clinical Practices (GCP) and applicable regulations.

Safety & Quality

• Oversee safety reporting processes and ensure regulatory submissions are accurate and timely.
• Conduct quality control with a focus on audit/inspection readiness.

Administration and Reporting

• Maintain trackers, tables, and databases to ensure transparency in study progress.
• Participate in investigator meetings, quality audits, and training sessions.

Required Qualifications

Education

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related fields (BSc./MSc. preferred).

Experience

• Minimum 1–3 years of experience in clinical research, monitoring, or site management.
• Familiarity with eTMF systems, regulatory processes, and GCP guidelines.

Key Skills

• Strong understanding of clinical trial protocols and registries.
• Excellent communication and relationship-building skills.
• Ability to manage multiple tasks effectively and meet deadlines.

Application Process

Interested candidates are encouraged to apply before February 22, 2025. Ensure all necessary documents, including your resume, are updated and reflect your expertise.

Tagged as: Good Clinical Practice (GCP)