Clinical Research Scientist

Job Title: Clinical Research Scientist
Job Type: Full-time | Permanent | Contractual/Temporary
Location: Mumbai, Maharashtra
Pay: ₹2,69,526.33 – ₹9,96,330.85 per year
Schedule: Day shift
Work Location: In person

Benefits:

Health insurance

Key Responsibilities:

1. Protocol Development & Study Design

Develop clinical trial protocols, investigator brochures, and informed consent forms
Contribute to designing study methodology and endpoints in alignment with scientific and regulatory standards

2. Clinical Trial Management

Collaborate with Clinical Operations on site selection, study start-up, and trial oversight
Monitor data quality and participant safety via ongoing data and safety review
Resolve protocol deviations, assess adverse events, and manage other study-related issues

3. Data Analysis & Reporting

Coordinate with data management and biostatistics teams for data analysis
Assist in interpreting clinical data and preparing CSRs, publications, and regulatory submissions (IND, NDA, etc.)

4. Regulatory & Compliance

Ensure compliance with ICH-GCP, FDA, EMA, and relevant global regulations
Liaise with regulatory bodies and ethics committees throughout the study lifecycle

5. Cross-Functional Collaboration

Work with R&D, medical writing, pharmacovigilance, and regulatory affairs teams
Act as a scientific liaison for investigators, KOLs, and internal stakeholders

Qualifications:

Education:

Advanced degree (PharmD, PhD, MD, or equivalent) in Life Sciences, Medicine, or Pharmacy

Experience:

3–6 years in clinical research (pharma, biotech, or CRO environments preferred)
Deep knowledge of clinical trial design, drug development, and regulatory landscapes

Skills: