Position: Study Start-Up Submissions Manager
Location: Remote (Based in Delhi, India)
Department: Site Activation & Maintenance
Job ID: 11221
Employment Type: Full-Time (Remote)
Job Summary
Medpace is seeking an experienced Study Start-Up Submissions Manager to join our Clinical Operations team in India. This remote position (based in Delhi) involves overseeing and managing all aspects of regulatory submissions and site activation activities across India and the APAC region.
At Medpace, we value expertise, accountability, and collaboration. Our employees are empowered to take initiative, think critically, and contribute to global clinical research excellence. In return, we offer challenging projects, clear career growth, and international exposure.
Key Responsibilities
Conduct close follow-up of Clinical Trial submissions to the Drugs Controller General of India (DCGI), including face-to-face visits.
Facilitate meetings with DCGI and provide regulatory consultation support as needed.
Efficiently manage and execute all aspects of local and regional (APAC) study start-up activities.
Independently communicate with Sponsors, Sites, IRBs/ECs, and Regulatory Authorities (CDSCO and DCGI).
Perform quality checks on submission packages and essential site documents.
Prepare and approve Informed Consent Forms (ICFs) in accordance with regulatory standards.
Review and interpret relevant regulatory guidelines to proactively address start-up challenges.
Represent Medpace during bid defense meetings, audits, and general capabilities presentations.
Qualifications
Education: Bachelor’s degree in a life science or healthcare-related field.
Experience:
Minimum 8 years of regulatory submissions experience in clinical research (preferably within a CRO).
Prior experience as CRA or in Project Management is advantageous.
Strong local experience mandatory for RSC level.
Local and Regional APAC experience required for RSM level.
Skills:
Proven experience in regulatory submissions and communication with ECs/RAs.
Strong oral and written communication skills.
Ability to prepare, review, and submit high-quality regulatory documents and formulate responses to regulatory queries.
About Medpace
Medpace is a leading, full-service Clinical Research Organization (CRO) providing Phase I–IV development services to the biotechnology, pharmaceutical, and medical device sectors.
Our mission is to accelerate global drug development through scientific discipline, quality, and innovation.
Therapeutic Expertise Includes:
Oncology
Cardiology
Metabolic and Endocrine Disorders
Central Nervous System (CNS)
Anti-Viral and Anti-Infective
Headquarters: Cincinnati, Ohio, USA
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 & benefits package
Attractive paid time off (PTO) policy
Structured career development pathways
Company-sponsored employee recognition and wellness programs
Opportunities for international collaboration
Awards & Recognition
Forbes: America’s Most Successful Midsize Companies (2021–2024)
Life Science Leader: CRO Leadership Awards for Expertise, Quality, Capabilities, Reliability & Compatibility
Next Steps
A Medpace recruiter will review your qualifications.
If shortlisted, you’ll be contacted with further details about the next steps in the selection process.
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