Medpace, a leading global Clinical Research Organization (CRO), is seeking a Study Start-Up Submissions Coordinator to join our Clinical Operations team in Navi Mumbai, India. This is a full-time, office-based role that plays a crucial part in ensuring the timely activation of investigative sites for clinical trials.
If you are looking for a rewarding career in clinical research with opportunities for professional growth, this role is perfect for you. At Medpace, we value expertise, innovation, and teamwork, empowering our employees to make a real impact in the pharmaceutical and biotechnology industries.
Key Responsibilities:
- Prepare, review, and submit regulatory and ethics committee applications for clinical trial approvals
- Ensure compliance with ICH-GCP guidelines and local regulatory requirements
- Communicate with global study teams, sponsors, and investigative sites to facilitate study start-up
- Track submissions and ensure timely document filing
- Review and finalize essential documents required for site activation
- Provide regulatory expertise to study teams and advise on changing compliance requirements
- Identify and mitigate risks that may delay site activation
- Maintain direct contact with investigative sites during the study start-up process
Qualifications & Skills Required:
- Bachelor’s degree in Life Sciences or related field
- Minimum 1 year of experience in regulatory submissions, site activation, or clinical operations (CRO, Pharma, or Site experience preferred)
- Strong knowledge of Microsoft Office, ICH-GCP, and regulatory guidelines
- Hands-on experience in preparing and submitting documents to Ethics Committees (EC) and Regulatory Authorities (RA)
- Excellent communication, organizational, and problem-solving skills
- Fluency in English (written and verbal)
Why Join Medpace?
Medpace is a top-rated CRO with a strong global presence, offering Phase I-IV clinical trial services across oncology, cardiology, metabolic diseases, CNS, and more.
Employee Benefits & Perks:
✅ Competitive salary & benefits
✅ Flexible work environment
✅ Structured career growth opportunities
✅ Company-sponsored training & development programs
✅ Employee wellness initiatives
✅ Recognition & awards for outstanding performance
Awards & Recognition:
🏆 Forbes America’s Most Successful Midsize Companies (2021-2024)
🏆 CRO Leadership Awards (Life Science Leader Magazine)
