Senior Study Start-Up Submissions Coordinator (Remote – Delhi)
Location: Remote (based in Delhi), India
Job Description:
Medpace is seeking an experienced and proactive Senior Study Start-Up Submissions Coordinator to join our Clinical Operations team. This full-time, remote-based role focuses on overseeing regulatory submissions, coordinating clinical trial activation processes, and interacting with DCGI, CDSCO, and other key regulatory bodies across India and the APAC region.
Key Responsibilities:
Closely follow up on clinical trial submissions to the Drugs Controller General of India (DCGI); includes in-person visits as required.
Facilitate and participate in DCGI meetings and consultations to support submission processes.
Oversee and execute local and regional APAC clinical study start-up activities efficiently.
Act as the primary contact for sponsors, clinical sites, IRBs/ECs, and regulatory authorities (CDSCO and DCGI).
Perform quality control checks on submission documents and site essential files to ensure completeness and compliance.
Draft and approve Informed Consent Forms (ICFs) tailored to regional regulatory requirements.
Stay up-to-date with current regulations and proactively develop solutions to address start-up challenges.
Represent the start-up team during bid defense meetings, client presentations, and regulatory audits.
Qualifications:
Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
8+ years of experience in clinical regulatory submissions, preferably with a CRO.
Hands-on experience in preparing, reviewing, and submitting regulatory documents to Ethics Committees (EC) and Regulatory Authorities (RA), including crafting query responses.
Strong understanding of local Indian regulations; regional APAC experience preferred.
Excellent oral and written communication skills.
Why Join Medpace?
Remote flexibility with structured career progression
Competitive salary and benefits
Extensive paid time off and leave policies
Supportive environment for professional growth
Wellness initiatives and regular employee recognition events
About Medpace:
Medpace is a leading clinical contract research organization (CRO) delivering full-service Phase I–IV clinical development solutions. Headquartered in Cincinnati, Ohio, with operations in 40+ countries and a team of 5,000+ professionals, Medpace supports drug and medical device development across diverse therapeutic areas.
Awards & Recognition:
Featured by Forbes as one of America's Most Successful Midsize Companies (2021–2024)
Consistently awarded CRO Leadership Awards for quality, reliability, and performance
Estimated Salary: ₹13 – ₹18 LPA (based on qualifications and market benchmarks)
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