Sanofi is Hiring for a Central Clinical Research Associate for Registries in Hyderabad

Sanofi is a pioneering global healthcare company, driven by a singular purpose: we chase the miracles of science to improve people’s lives. Our teams across the world are dedicated to transforming the practice of medicine, making the impossible possible for patients.

At Sanofi, you’ll be part of a diverse and growing portfolio, from established medicines that millions rely on to groundbreaking advances in immunology and chronic disease care. Your work will have a global impact, helping to deliver treatments to individuals with diabetes, cardiovascular disease, and complications from transplants.

Fueled by cutting-edge technology, we are accelerating innovation and expanding access to healthcare faster than ever before. If you are ready to push boundaries, leverage the power of AI and digital tools, and shape the future of healthcare, Sanofi is where your ambition meets impact.

About the Role: Central CRA (Clinical Research Associate) – Registries

Job Title: Central CRA (Clinical Research Associate)- Registries
Location: Hyderabad, India
Job Type: Permanent and Full-time
Travel: As per business need

This is a fantastic opportunity to join our Sanofi Business Operations (SBO) team in Hyderabad. SBO is an internal resource organization that centralizes processes to support various global functions within Sanofi, including Specialty Care, Vaccines, General Medicines, and R&D.[1]

As a Central CRA, you will serve as the primary liaison for Principal Investigators and other site staff involved in conducting rare disease registries. This role is crucial in ensuring the smooth execution of clinical studies and maintaining high standards of quality and compliance.

Key Responsibilities:

1. Feasibility and Study Start-up:

• Participate in the site selection process.
• Assist in collecting and reviewing site documents for submissions to Health and Regulatory Authorities, as well as Ethics Committees (EC) and Institutional Review Boards (IRB).
• Prepare and manage EC submissions, including cover letters and follow-up correspondence.
• Oversee the site contract process, from document collection to budget negotiation.
• Customize and manage the Informed Consent Form (ICF) for each site.
• Ensure all start-up documentation is correctly filed in the electronic Trial Master File (eTMF).

2. Site Monitoring (Remote and Onsite):

• Perform remote site management activities for assigned registries, including Site Selection, Initiation, Routine Monitoring, and Close-Out Visits.
• Conduct onsite monitoring visits where local hub affiliates are located.
• Review study data from various sources, ensuring completeness and accuracy of the electronic Case Report Form (eCRF).
• Collaborate with the Data Management group and escalate issues as needed.

3. Site Management:

• Monitor patient enrollment and status.
• Ensure site facilities and staff are adequate and well-trained.
• Develop strong, collaborative relationships with investigational sites and stakeholders.

4. Safety & Quality:

• Ensure proper safety reporting processes are in place at each site.
• Maintain an “audit/inspection readiness” mindset, conducting critical analysis of issues and implementing Corrective and Preventive Actions (CAPA) when necessary.

5. Study Administration:

• Maintain and update all study-related trackers and databases.
• Manage the investigator payment process, where applicable.
• Ensure TMF compliance throughout the study.
• Participate in local and international study meetings and trainings.

About You:

Experience:

• 3+ years of experience in Clinical Research & Development, including clinical trial monitoring.
• Experience in rare diseases, observational studies, or real-world evidence is a plus.
• Proven experience working in global projects and a matrix environment.

Skills and Qualifications:

• Education: Degree in a Pharmacy/scientific discipline or a related Life Science degree.
• Technical Skills:
  • Thorough understanding of Good Clinical Practice (GCP) guidelines.
  • Knowledge of regulatory requirements (FDA, EMA, etc.).
  • Proficiency in clinical trial processes, data management, and medical terminology.
  • Competent with Microsoft Office products.
• Soft Skills:
  • Excellent written and oral communication skills in English.
  • Strong attention to detail, problem-solving abilities, and project management skills.
  • Adaptability, strong interpersonal skills, and effective time management.
  • High ethical judgment and integrity.

How to Apply?

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Why Work With Us?

At Sanofi, we are committed to your professional growth and development. We provide a supportive and inclusive environment where you can pursue progress and discover the extraordinary. We offer equal opportunities to all, regardless of background, and are dedicated to creating a diverse and equitable workplace.

If you are ready to make a difference and contribute to our mission of improving people’s lives, we encourage you to apply.

Apply Now and Shape the Future of Healthcare with Sanofi!