Clinical Study Leader | Randstad India | Mumbai, Maharashtra
Job Description
Summary
Randstad India is hiring an experienced Clinical Study Leader in Mumbai, Maharashtra, to oversee clinical research projects from planning to completion. This role is ideal for professionals with deep expertise in clinical operations, clinical trial management, and regulatory compliance in India. As a Clinical Study Leader at Randstad India, you will manage multi-functional study teams, ensure adherence to ICH-GCP standards, and optimize clinical trial processes while maintaining high-quality outcomes. Join our team to advance your career in clinical research leadership while driving impactful medical studies.
📊 Job Details at a Glance
| Job Title | Clinical Study Leader |
|---|---|
| Location | Mumbai, Maharashtra |
| Employment Type | Permanent |
| Shift | Day Shift |
| Experience Level | 10+ Years in Clinical Operations |
| Education Requirement | Life Sciences / Medical / Pharmacy Graduate |
| Tools & Technologies | Clinical Trial Management Systems (CTMS), MS Office |
| Industry | Clinical Research, Pharmaceutical, Healthcare |
🛠️ Key Responsibilities
- Plan and execute clinical studies in line with quality standards, timelines, and budget, from study synopsis to archiving.
- Build and lead cross-functional study teams, including internal staff and external vendors, tailored to study complexity.
- Organize and schedule study team meetings, track progress, and ensure follow-up on agreed actions.
- Establish and maintain strong working relationships across study teams and relevant functions.
- Monitor adherence to clinical trial regulations and ICH-GCP standards, ensuring compliance throughout the study lifecycle.
- Identify process improvement opportunities to enhance efficiency and quality in clinical operations.
- Provide guidance and mentorship to study team members on best practices in clinical research and compliance.
✅ Required Skills & Competencies
- Strong knowledge of clinical operations, study management, and field operations (CRA experience preferred).
- Understanding of drug development and registration processes in India.
- Expertise in ICH-GCP guidelines, clinical trial processes, and regulatory compliance.
- Excellent leadership, communication, and team management skills.
- Ability to drive quality, compliance, and process improvement initiatives.
🎓 Qualifications
- 10+ years of experience in clinical operations or clinical study leadership roles.
- Graduate or postgraduate degree in Life Sciences, Pharmacy, or related fields.
- Prior experience in field operations (CRA role) is an asset.
- Familiarity with clinical trial management systems (CTMS) and other study tracking tools.
🚀 Why Join Randstad India?
- Lead high-impact clinical research projects with cross-functional teams.
- Gain exposure to clinical trial management, regulatory compliance, and study team leadership.
- Opportunity to work in a dynamic, growth-oriented, and collaborative environment.
- Contribute to innovative healthcare solutions and drug development initiatives.
📢 Apply Now
Advance your career as a Clinical Study Leader at Randstad India in Mumbai, Maharashtra. Lead clinical research projects, ensure compliance with regulatory standards, and drive process improvements across multi-functional teams.