Syneos Health is seeking a Clinical Trial Assistant (CTA)/ Study Start-Up Specialist in Mumbai to manage study start-up activities and ongoing clinical trial documentation. The role involves collaborating with internal teams, external stakeholders, and regulatory bodies to ensure smooth trial initiation and compliance.
Key Responsibilities:
- Act as the primary contact for local study teams and external partners.
- Manage study start-up activities, including document preparation, submissions, and approvals.
- Coordinate with Health Authorities (HA) and Ethics Committees (EC) for protocol approvals, amendments, and essential documentation.
- Prepare and review Informed Consent Forms (ICF) and ensure compliance with regulatory requirements.
- Maintain electronic Trial Master File (eTMF) with all necessary regulatory documents.
- Support feasibility assessments and site selection for clinical trials.
- Ensure adherence to GCP, ICH guidelines, and local regulatory standards.
- Assist in audit preparations and corrective action plans as needed.
- Update national clinical trial registries when applicable.
Qualifications & Experience:
- Bachelor’s degree in Life Sciences or related field.
- 3+ years of experience in clinical trial start-up activities, including HA/EC submissions.
- Strong knowledge of GCP, ICH guidelines, and Indian regulatory requirements.
- Excellent organizational, time management, and decision-making skills.
- Experience in cross-functional team collaboration and managing multiple priorities.
- Ability to analyze risks and implement effective solutions.
Why Join Syneos Health?
✅ Career Growth: Opportunities for professional development and progression.
✅ Supportive Culture: Engaged leadership and a Total Self work environment.
✅ Global Impact: Work with a diverse team across 110 countries.
✅ Innovation-Driven: Contribute to accelerating life-changing therapies.
Advertisement
How to Apply?
Advertisement
