Job Title: Senior Study Start-up Submissions Coordinator
Job ID: 11218
Location: Remote (based in Delhi, India)
Department: Site Activation & Maintenance
Company: Medpace
Job Type: Full-time
Job Summary
Medpace is seeking a remote-based Senior Study Start-up Submissions Coordinator to join the Clinical Operations team in Delhi, India. The role involves managing and executing clinical trial submissions, ensuring compliance with regulatory authorities, and facilitating effective communication with key stakeholders.
Key Responsibilities
Perform close follow-up of clinical trials submitted to Drugs Controller General of India (DCGI); face-to-face visits expected.
Facilitate meetings with DCGI and support consultation processes when required.
Manage and execute all aspects of local and Regional APAC study start-up.
Independently interact with Sponsors, sites, IRBs/ECs, and regulatory agencies (CDSCO, DCGI).
Perform quality checks on submission documents and site essential documents.
Prepare and approve Informed Consent Forms (ICFs).
Review regulations and proactively resolve start-up issues and challenges.
Present in bid defenses, general capabilities meetings, and audits.
Qualifications
Bachelor’s degree with 8+ years of regulatory submissions experience in clinical research (preferably with a CRO).
Experience may include CRA or Project Management.
Strong local experience mandatory for RSC level; local + APAC regional experience mandatory for RSM level.
Strong oral and written communication skills.
Hands-on experience in preparing, reviewing, and submitting regulatory documentation to ECs and RAs, including formulating responses to queries.
About Medpace
A full-service global CRO providing Phase I–IV clinical development services to biotech, pharma, and medical device industries.
Mission: Accelerate the global development of safe and effective medical therapeutics.
Expertise in multiple therapeutic areas: oncology, cardiology, metabolic diseases, endocrinology, CNS, anti-viral, and anti-infective.
Headquartered in Cincinnati, Ohio with 5,000+ employees across 40+ countries.
Why Join Medpace?
People. Purpose. Passion. Make a Difference Tomorrow.
Impact lives across key therapeutic areas.
Opportunities for career advancement, recognition, and international exposure.
Perks & Benefits
Flexible work environment.
Competitive compensation and benefits.
PTO packages.
Structured career growth.
Employee appreciation events.
Health and wellness initiatives.
Awards & Recognition
Forbes: One of America’s Most Successful Midsize Companies (2021–2024).
Consistently recognized with CRO Leadership Awards for expertise, quality, capabilities, reliability, and compatibility.
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