Position: Senior Study Start-Up Submissions Coordinator
Location: Remote (Based in Delhi, India)
Department: Site Activation & Maintenance
Job ID: 11218
Employment Type: Full-Time (Remote)
Job Summary
Medpace is seeking a Senior Study Start-Up Submissions Coordinator to join our Clinical Operations team in India.
This remote-based position (Delhi) involves managing and coordinating regulatory submissions and start-up activities across India and the APAC region.
At Medpace, we foster a culture of expertise and empowerment. Our employees are encouraged to take initiative, leverage their experience, and deliver excellence in clinical research. In return, we offer engaging projects, global exposure, and structured career development opportunities.
Key Responsibilities
Conduct close follow-up of Clinical Trial submissions with the Drugs Controller General of India (DCGI); face-to-face visits expected.
Facilitate and coordinate meetings with DCGI and provide support for consultation processes as required.
Oversee and manage all aspects of local and regional (APAC) start-up activities efficiently and independently.
Maintain direct communication with Sponsors, Sites, IRBs/ECs, and Regulatory Authorities (CDSCO, DCGI).
Perform quality control checks on submission packages and essential site documents.
Prepare and approve Informed Consent Forms (ICFs) in compliance with applicable regulations.
Review and interpret regulatory requirements to proactively identify and resolve start-up issues.
Represent Medpace during bid defense meetings, audits, and capability presentations.
Qualifications
Education: Bachelor’s degree in a life sciences or healthcare-related field.
Experience:
Minimum 8 years of regulatory submissions experience in clinical research (preferably within a CRO).
Previous experience as a Clinical Research Associate (CRA) or in Project Management is an advantage.
Strong local experience required for RSC level; Local and Regional APAC experience mandatory for RSM level.
Skills:
Strong oral and written communication skills.
Proven hands-on experience in preparing, reviewing, and submitting regulatory documentation to ECs and RAs.
Ability to formulate accurate and timely responses to regulatory queries.
About Medpace
Medpace is a full-service Clinical Research Organization (CRO) providing Phase I–IV clinical development services to biotechnology, pharmaceutical, and medical device industries.
Our mission is to accelerate global development of safe and effective medical therapeutics through scientific rigor and operational excellence.
Therapeutic Expertise Includes:
Oncology
Cardiology
Metabolic & Endocrine Disorders
Central Nervous System (CNS)
Anti-Viral & Anti-Infective Therapies
Headquarters: Cincinnati, Ohio
Global Presence: 40+ countries
Employees: 5,000+
Why Join Medpace?
People. Purpose. Passion. Make a Difference Tomorrow — Join Us Today.
We Offer:
Flexible remote work environment
Competitive salary and benefits package
Attractive PTO (Paid Time Off) policy
Structured career paths with growth opportunities
Company-sponsored employee events and appreciation programs
Health and wellness initiatives
Awards & Recognition
Forbes: America’s Most Successful Midsize Companies (2021–2024)
Life Science Leader: CRO Leadership Awards (Expertise, Quality, Reliability, and Compatibility)
Next Steps
A Medpace representative will review your application.
If shortlisted, you’ll be contacted with details on the next steps in the selection process.
Apply Now
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