Senior Study Start-Up Submissions Coordinator (Remote – Delhi, India)
Location: Remote (Based in Delhi, India)
Department: Site Activation and Maintenance
Company: Medpace
Job ID: 11218
Category: Clinical Research / Regulatory Submissions
Job Overview
Medpace is seeking an experienced Senior Study Start-Up Submissions Coordinator to support clinical trial activation and regulatory submissions across India and the APAC region. This is a full-time remote role based in Delhi. The position is ideal for professionals with strong regulatory expertise, deep understanding of DCGI submissions, and hands-on coordination experience in clinical research.
Medpace fosters a culture built on scientific excellence, accountability, and collaboration. Team members are encouraged to apply their skills to drive efficient clinical development while contributing to global research innovation.
Key Responsibilities
Conduct close follow-up on clinical trial submissions to the Drugs Controller General of India (DCGI), including required onsite and face-to-face visits.
Facilitate meetings and coordinate consultation activities with DCGI and other regulatory authorities.
Lead and manage all aspects of local and regional APAC study start-up activities, ensuring timely and compliant submissions.
Independently communicate with sponsors, clinical sites, Institutional Review Boards (IRBs), Ethics Committees (ECs), CDSCO, and DCGI.
Perform thorough quality checks on submission packages and site essential documents.
Prepare, review, and approve Informed Consent Forms (ICFs) in accordance with regulatory standards.
Evaluate regulatory requirements proactively to identify solutions for start-up challenges.
Present and represent Medpace during bid defense meetings, capability presentations, and audits.
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, or related discipline.
More than 8 years of regulatory submissions experience in clinical research, preferably within a CRO.
Strong local regulatory knowledge and mandatory hands-on India experience at RSC level; local + regional APAC experience required for RSM-level expectations.
Prior experience in roles involving CRA, project management, or regulatory submissions is preferred.
Demonstrated experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees (ECs) and Regulatory Authorities (RA).
Proven ability to formulate responses to regulatory queries.
Strong written and verbal communication skills.
About Medpace
Medpace is a global, full-service Contract Research Organization (CRO) providing Phase I–IV clinical development services to pharmaceutical, biotechnology, and medical device organizations. With more than 5,000 employees across 40+ countries, Medpace applies a scientifically driven approach to accelerate the development of safe and effective medical therapies. Key therapeutic expertise includes oncology, cardiology, metabolic disorders, endocrinology, CNS, antiviral, and anti-infective research.
Why Join Medpace?
Flexible work environment
Competitive compensation and comprehensive benefits
Generous paid time off (PTO) structure
Clear and structured pathways for professional development
Employee-focused initiatives and wellness programs
Company-sponsored recognition events
Industry-recognized workplace awards, including Forbes "America’s Most Successful Midsize Companies" (2021–2024) and multiple CRO Leadership Awards
Application Process
After submission, your profile will be reviewed by the Medpace recruitment team. If shortlisted, you will be contacted with information regarding the next steps in the hiring process.
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Remote - Africa | Riga | Texas | Hammond | Lousiana | Bountiful | Green Way | French | Medan | Manipal | Leinster | Switzerland | Faridabad | Remote - South America (Latin Americal) | Springville | Minnesota | Melbourne | Remote - Europe | Slovakia | Blue Bell | Belgium | Xzagreb | Remote | Remote - Middle East | Victoria | Lenexa | Nairobi | Ireland | Zaragoza | Tulsa | McFarland | Bishop | Castlebar | Remote, USA | Thailand | Hungary |Bucharest :
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