Job Title: Study Start-up Submissions Manager
Job ID: 11221
Location: Remote (based in Delhi, India)
Department: Site Activation & Maintenance
Company: Medpace, Inc.
Job Type: Full-time (Regular)
Job Summary
Medpace is seeking an experienced Study Start-up Submissions Manager to join the Clinical Operations team. This is a remote-based position in Delhi.
At Medpace, we empower teams to use their expertise, take initiative, and deliver solutions that support our clients. Our employees are rewarded with career growth opportunities, global exposure, and recognition for their contributions.
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 support consultation processes when required.
Manage and execute all aspects of local and Regional APAC start-up activities.
Independently interact with Sponsors, Sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs), and regulatory agencies (including CDSCO and DCGI).
Perform quality checks on submission documents and essential site documents.
Prepare and approve Informed Consent Forms (ICFs).
Review regulations and develop proactive solutions to start-up issues and challenges.
Represent Medpace during bid defenses, capability meetings, and audits.
Qualifications
Bachelor’s degree with 8+ years of regulatory submissions experience in clinical research (preferably with a CRO).
Previous experience as a CRA or in project management is desirable.
Strong local regulatory experience mandatory for RSC level; both local and Regional APAC experience mandatory for RSM level.
Hands-on experience in preparing, reviewing, and submitting regulatory documentation to ECs and Regulatory Authorities (RAs), including drafting responses to queries.
Strong oral and written communication skills.
About Medpace
Medpace is a full-service Clinical Research Organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries.
Mission: Accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach.
Expertise: Local regulatory knowledge and therapeutic experience across oncology, cardiology, metabolic diseases, endocrinology, CNS, antiviral, and anti-infective areas.
Headquarters: Cincinnati, Ohio
Global Presence: 40+ countries with 5,000+ employees
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
For over 30 years, Medpace has made a positive impact on patients and families worldwide by supporting development in multiple therapeutic areas.
Perks & Benefits
Flexible work environment
Competitive compensation & benefits package
Attractive PTO plans
Structured career paths with professional growth opportunities
Company-sponsored employee events
Health & wellness initiatives
Awards & Recognition
Forbes: One of America’s Most Successful Midsize Companies (2021–2024)
Life Science Leader Magazine: Multiple CRO Leadership Awards (expertise, quality, reliability, compatibility)
Next Steps
A Medpace team member will review your application. If shortlisted, you will be contacted regarding next steps.
🌍 Learn more: Medpace Careers
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