Job Title: Study Start-up Submissions Manager (Remote – Delhi)
Company: Medpace
Location: Remote (Based in Delhi, India)
Department: Site Activation & Maintenance
Job ID: 11221
Job Summary:
Medpace is seeking a remote-based, full-time Study Start-up Submissions Manager to join its Clinical Operations team in India. This role requires hands-on regulatory experience, active communication with authorities, and expertise in submission strategy and execution within clinical research. The position offers an opportunity to support local and regional startup activities and contribute significantly to global clinical development programs.
Key Responsibilities:
Monitor and follow up on clinical trial submissions to the Drugs Controller General of India (DCGI); conduct in-person visits as needed.
Coordinate and facilitate meetings with DCGI and support relevant consultation processes.
Lead and execute all aspects of local and APAC regional study start-up activities.
Act as primary liaison with Sponsors, investigative sites, IRBs/ECs, and regulatory authorities (including CDSCO and DCGI).
Perform quality control of submission packages and site essential documents.
Prepare and approve informed consent forms in compliance with applicable guidelines.
Analyze regulations to anticipate and solve potential startup challenges.
Represent the organization during bid defenses, capabilities meetings, and audits.
Qualifications:
Bachelor’s degree with 8+ years of regulatory submissions experience in clinical research, preferably within a CRO.
Prior experience in CRA or project management roles is an added advantage.
Mandatory hands-on local experience for RSC level; both local and APAC regional experience required for RSM level.
Strong verbal and written communication abilities.
Proven experience in preparing, reviewing, and submitting regulatory documentation to ECs and regulatory agencies, including query response formulation.
About Medpace:
Medpace is a scientifically driven full-service CRO supporting Phase I–IV clinical development for the biotechnology, pharmaceutical, and medical device sectors. Headquartered in Cincinnati, Ohio, Medpace has a global presence with over 5,000 employees across 40+ countries and provides regulatory and therapeutic expertise in all major clinical areas.
Why Join Medpace?
Flexible working environment
Competitive salary and benefits package
Generous PTO structure
Clearly defined career development paths
Company-sponsored employee recognition and engagement initiatives
Comprehensive wellness programs
Awards & Recognition:
Named one of America’s Most Successful Midsize Companies by Forbes (2021–2024)
Winner of multiple CRO Leadership Awards from Life Science Leader magazine
What Happens Next:
If selected, a Medpace recruiter will contact you with next steps in the hiring process.
EO/AA Employer: M/F/Disability/Vets
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