Medpace, a leading global Clinical Research Organization (CRO), is hiring a Study Start-up Submissions Coordinator for its Clinical Operations team in Navi Mumbai. This role is crucial for ensuring the smooth activation of investigative sites for clinical trials across various phases. If you have experience in regulatory submissions, ethics committee approvals, and site activation, this is an excellent opportunity to grow your career in the pharmaceutical and clinical research industry.
Key Responsibilities:
- Prepare, review, and submit regulatory documents to Ethics Committees (EC) and Regulatory Agencies
- Ensure compliance with ICH-GCP guidelines and local regulatory requirements
- Communicate with global study teams to track study progress and resolve submission-related issues
- Review and finalize essential documents required for site activation
- Act as the primary contact for ethics and regulatory submissions
- Track submissions and maintain documentation for audit readiness
- Advise sponsors on changing regulatory requirements in India
Qualifications & Skills Required:
- Bachelor’s degree in Life Sciences, Pharmacy, or related field
- 1+ years of experience in regulatory submissions, site activation, or clinical trial start-up (CRO, Pharma, or Site experience preferred)
- Strong knowledge of ICH-GCP, Indian regulatory guidelines, and clinical trial processes
- Hands-on experience in preparing and submitting documents to CDSCO, EC, and other regulatory bodies
- Excellent communication, organizational, and problem-solving skills
- Proficiency in Microsoft Office
- Fluency in English (written and verbal)
Why Join Medpace?
Medpace is a top-ranked CRO with a strong global presence, offering:
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- Competitive salary & benefits
- Structured career growth in clinical research
- Flexible work environment
- Employee wellness programs
- Recognition & awards for excellence
