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CENTRAL CLINICAL RESEARCH ASSOCIATE (CRA)

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SANOFI

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The Central CRA will support clinical and registry studies from different stages of the study lifecycle. The role combines site management, monitoring, study start-up, regulatory coordination, documentation, and collaboration with global clinical teams.

The successful candidate will work closely with investigators, site personnel, vendors, data management teams, and other stakeholders to help ensure that study activities are conducted according to approved protocols, quality standards, and applicable regulations.

This is a role that requires both strong clinical research knowledge and excellent stakeholder management skills.

Job Overview

Particulars Details
Position CENTRAL CLINICAL RESEARCH ASSOCIATE (CRA)
Company SANOFI
Job Type
Category / Department CDM
Application Mode Online

🏢 About SANOFI

anofi is a global biopharmaceutical company focused on discovering and developing innovative medicines and vaccines.

The organization combines scientific research, technology, and global collaboration to address important healthcare needs. Its work spans areas including innovative medicines and vaccines, with a strong focus on improving outcomes for patients around the world.

Sanofi has continued to evolve throughout its history, building a global presence while investing in scientific research, new technologies, and innovative approaches to healthcare. The company's current direction also includes the use of advanced technologies such as artificial intelligence to support areas of research and drug discovery.

For professionals interested in clinical research, Sanofi offers opportunities to work in an international environment where scientific knowledge, collaboration, and patient-focused thinking come together.

🎯 COMPANY PURPOSE

Sanofi's work is centered around using scientific innovation to improve people's lives. Its teams work toward developing medicines and vaccines that can address healthcare challenges and support healthier communities worldwide.

🚀 COMPANY VISION

The company's broader ambition is to help create a healthier and more resilient world by combining scientific research, innovation, technology, and global collaboration.

💡 Editor's Note / Preparation Tip

📚 EDITORIAL NOTES

📌 This is an experienced-level Clinical Research opportunity requiring 5+ years of relevant experience.
📌 Candidates should carefully review the role requirements before applying.
📌 Professionals with direct monitoring and site management experience should highlight these areas prominently on their resumes.
📌 Experience in global clinical trials, registries, observational studies, or rare disease programs may strengthen an application.
📌 Candidates should ensure their resume accurately reflects their actual clinical research experience and technical expertise.
📌 Always verify the current application status and closing date through the official recruitment channel before applying.

📄 RESUME PREPARATION TIPS

1️⃣ Clearly mention your total years of Clinical Research and CRA experience.
2️⃣ Highlight specific monitoring activities such as SSV, SIV, RMV, and COV.
3️⃣ Include experience with TMF/eTMF, ICH-GCP, IRB/EC submissions, eCRF review, and source data verification.
4️⃣ Mention global studies, therapeutic areas, study phases, or registry projects you have genuinely worked on.
5️⃣ Use measurable achievements wherever possible, such as the number of sites managed, countries supported, or studies monitored.

🎯 INTERVIEW PREPARATION

1️⃣ Revise the complete clinical trial lifecycle, from feasibility and start-up through close-out.
2️⃣ Prepare to explain your approach to remote and onsite monitoring.
3️⃣ Review ICH-GCP principles, essential documents, TMF/eTMF requirements, and regulatory compliance.
4️⃣ Be ready to discuss examples involving protocol deviations, CAPA, data queries, safety reporting, or site issues.
5️⃣ Prepare real examples that demonstrate stakeholder management and your ability to handle challenging clinical sites.

💡 PROFESSIONAL TIPS

🚀 Keep your knowledge of global clinical research regulations current.
📊 Develop strong skills in study tracking, documentation, and clinical data review.
🌍 Gain experience working with international teams and different cultural working styles.
🧠 Strengthen your problem-solving approach by learning how to investigate deviations and identify root causes.
📈 Build expertise in emerging areas such as RWE, decentralized trials, digital clinical research, and AI-enabled clinical operations.

📝 Job Description

🚨 SANOFI IS HIRING | CENTRAL CLINICAL RESEARCH ASSOCIATE (CRA) 🧬🔬

📍 Hyderabad | 5+ Years Experience | Full-Time

Are you an experienced Clinical Research professional looking for an opportunity to work on global clinical research programs?

Sanofi is looking for a Central Clinical Research Associate (CRA) to join its Sanofi Business Operations (SBO) team in Hyderabad. This role is designed for professionals who have experience in clinical trial monitoring, site management, study start-up, regulatory documentation, and clinical research operations.

The position offers the opportunity to contribute to global registry studies, including work involving rare diseases, while collaborating with investigators, vendors, and international stakeholders. If you have hands-on experience with ICH-GCP, eTMF/TMF, eCRF review, site monitoring, regulatory submissions, and clinical operations, this could be an exciting next step in your career. 🚀

📌 JOB DETAILS

🏢 Company: Sanofi
💼 Position: Central Clinical Research Associate (CRA)
📍 Location: Hyderabad, India
🏛️ Department: Sanofi Business Operations (SBO)
💼 Employment Type: Full-Time
🎓 Qualification: Degree in Pharmacy, Life Sciences, or another relevant scientific discipline
💼 Experience: 5+ Years
📅 Application Deadline: 24 September 2026
🧬 Industry: Pharmaceutical / Clinical Research

🎓 QUALIFICATION & EXPERIENCE

Candidates with a relevant degree in Pharmacy, Life Sciences, or a scientific field may be considered.

Relevant educational backgrounds may include:

✔ B.Pharm
✔ M.Pharm
✔ Pharm.D
✔ B.Sc / M.Sc Life Sciences
✔ Biotechnology
✔ Microbiology
✔ Biochemistry
✔ Clinical Research
✔ Other relevant scientific or Life Sciences disciplines

💼 Experience Required:
Candidates should have at least 5 years of relevant Clinical Research experience, preferably including clinical trial monitoring and exposure to global clinical projects.

Experience in the following areas can be advantageous:

🔹 Rare Disease Studies
🔹 Registry Studies
🔹 Observational Research
🔹 Real-World Evidence (RWE)
🔹 Global Clinical Operations

🤝 SOFT SKILLS

🌟 Strong communication and presentation abilities
🌟 Stakeholder relationship management
🌟 Effective time management
🌟 Project coordination skills
🌟 Logical problem-solving approach
🌟 Ethical and responsible decision-making
🌟 Ability to adapt to changing priorities
🌟 High attention to detail
🌟 Technical and scientific writing skills
🌟 Ability to work effectively in international teams

🌍 WHY CONSIDER A CAREER WITH SANOFI?

🔬 Work on international clinical research programs.
🌍 Gain exposure to global clinical operations and regulatory practices.
🧬 Opportunity to contribute to rare disease and registry research.
🤝 Collaborate with cross-functional and international teams.
📈 Build long-term expertise in clinical research and clinical operations.
📚 Access learning and professional development opportunities.
🌱 Work in a diverse environment with opportunities to grow professionally.
💡 Develop experience across different stages of the clinical study lifecycle.

💡 WHAT MAKES THIS OPPORTUNITY VALUABLE?

This role can be particularly relevant for experienced CRAs and clinical research professionals who want to expand their exposure to global studies, registry programs, rare disease research, study start-up, monitoring, and international clinical operations.

It also provides an opportunity to strengthen skills in stakeholder management, regulatory compliance, quality oversight, and cross-functional collaboration.

👥 WHO SHOULD CONSIDER APPLY?

This opportunity may be relevant for professionals currently working as:

🔹 Clinical Research Associate (CRA)
🔹 Senior CRA
🔹 Clinical Trial Monitor
🔹 Site Management Associate
🔹 Clinical Operations Specialist
🔹 Clinical Project Associate
🔹 Clinical Trial Coordinator
🔹 Clinical Research Professional
🔹 Site Management CRA
🔹 Registry Study Coordinator

🚀 Your one share could help someone find their next career opportunity!

🎯 Key Responsibilities

  • Support site feasibility assessments and site selection activities.
  • Coordinate activities associated with study start-up.
  • Collect and review essential regulatory and site documentation.
  • Assist with Ethics Committee (EC) and Institutional Review Board (IRB) submissions.
  • Support preparation and review of informed consent documentation.
  • Maintain study start-up records within the eTMF.
  • Conduct remote and onsite monitoring activities as required.
  • Participate in Site Selection Visits (SSV), Site Initiation Visits (SIV), Routine Monitoring Visits (RMV), and Close-Out Visits (COV).
  • Review source documents and electronic Case Report Forms (eCRFs).
  • Follow up with research sites to resolve clinical data queries.
  • Coordinate with Data Management and other cross-functional teams.
  • Monitor recruitment and retention activities at participating sites.
  • Support site personnel training and study-related communication.
  • Help ensure compliance with GCP requirements and applicable regulations.
  • Review and support safety reporting processes.
  • Assist with deviation assessments, root cause analysis, and CAPA activities.
  • Maintain study trackers, dashboards, and relevant databases.
  • Support investigator payment-related activities where applicable.
  • Ensure TMF and eTMF documentation remains complete and compliant throughout the study.
  • Participate in study meetings, audits, inspections, and other quality activities.
  • Collaborate with investigators, vendors, and international stakeholders.

💡 Required Qualifications & Skills

ICH-GCP principles Clinical Trial Monitoring Site Management Clinical Study Start-Up eTMF and TMF Management Remote & Onsite Monitoring Regulatory Compliance FDA / EMA Regulatory Awareness Ethics Committee / IRB Submissions Health Authority Documentation eCRF Review Query Management Source Data Verification CAPA Root Cause Analysis Safety Reporting Clinical Documentation Microsoft Office
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🚀 Career Guidance & Interview Insights

To help you succeed, we've compiled original preparation guides, resume keywords, and growth analytics for this category of role.

This CENTRAL CLINICAL RESEARCH ASSOCIATE (CRA) role is a chance to contribute directly to life sciences, patient care, or pharmaceutical advancements. You will work within strict compliance frameworks, ensure rigorous quality standards, and collaborate with technical or medical experts. It is a career path that blends scientific excellence with a deep sense of social purpose.

Expected Career Progression Roadmap:

Healthcare and pharmaceutical professionals grow through specialized scientific experience. Entry-level starts as Lab Technician, Chemist, or Quality Associate, progressing to Senior QA/QC Analyst. Advancement leads to Lab Supervisor, Clinical Project Manager, and senior management roles like Quality Director, VP of Regulatory Affairs, or Chief Scientific Officer.

Expected Technical & Behavioral Questions:

  • Q1: How do you ensure compliance with WHO/GMP guidelines during laboratory operations?
    Answer Tip: Mention strict adherence to Standard Operating Procedures (SOPs), detailed batch records, regular equipment calibration, and sanitization cycles.
  • Q2: What steps do you take when a quality deviation is detected in a product batch?
    Answer Tip: Outline immediate isolation of the batch, raising a deviation report, root cause analysis (RCA), and initiating CAPA (Corrective and Preventive Action).
  • Q3: How do you manage safety protocols while handling toxic chemicals?
    Answer Tip: Discuss using Material Safety Data Sheets (MSDS), wearing appropriate Personal Protective Equipment (PPE), proper ventilation, and chemical spill kits.
💡 Pro-Tip: Before your interview, research the company's recent news, product launches, and Glassdoor work reviews. Prepare 2-3 thoughtful questions for the interviewer regarding team dynamics and success metrics for this role.

To pass automated ATS (Applicant Tracking System) screening and catch the recruiter's eye, tailor your resume with the following tips:

  • Keywords to include: Quality Control (QC), GMP Compliance, FDA Regulations, SOP Documentation, HPLC/GC analysis, Batch Validation, Clinical Trials, Pharmacovigilance.
  • Format: List laboratory skills and instruments handled (e.g. HPLC, spectrophotometer) in a dedicated technical matrix.
  • Quantify Results: E.g., 'Validated 15 batch formulations under GMP guidelines with zero quality defects.'
Estimated Market Compensation in India:

Estimated compensation for this role type in India is ₹2,40,000 - ₹3,80,000 per annum (Fresher analyst). The actual salary package offered depends on factors such as company size, work mode (remote or on-site), individual technical proficiency, and negotiations during final HR rounds.

Suggested Professional Certifications:

Key credentials: GMP Certified Professional (ASQ), Certified Clinical Research Coordinator (CCRC), or specialized laboratory training certificates in high-performance liquid chromatography (HPLC) and safety standards.

Frequently Asked Questions

1️⃣ Who is the ideal candidate for this CRA position?
The opportunity is best suited to experienced Clinical Research professionals with 5+ years of relevant experience, particularly those with clinical trial monitoring and site management expertise.

2️⃣ What educational backgrounds are relevant?
Degrees in Pharmacy, Life Sciences, or other scientific disciplines may be relevant. Examples include B.Pharm, M.Pharm, Pharm.D, B.Sc, M.Sc, Biotechnology, Microbiology, Biochemistry, and Clinical Research.

3️⃣ Is experience with rare disease or registry studies mandatory?
The available information indicates that experience in rare disease, observational, RWE, or registry studies is advantageous. Candidates should review the official job requirements for the latest criteria.

4️⃣ What technical areas should candidates know?
Important areas include ICH-GCP, clinical monitoring, site management, study start-up, eTMF/TMF, regulatory submissions, eCRF review, query management, safety reporting, and CAPA.

5️⃣ Where is this position based?
The position is listed in Hyderabad, India, within the Sanofi Business Operations (SBO) team.

6️⃣ What career opportunities can this experience support?
This experience can support future career progression toward roles such as Senior CRA, Clinical Trial Lead, Clinical Project Manager, Clinical Operations Manager, or other global clinical research leadership positions.

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