Study Start-Up Submissions Manager – Structured Job Description
Company: Medpace
Function: Site Activation & Maintenance / Clinical Operations
Job ID: 12312
Location: Remote (Based in Delhi, India)
Employment Type: Full-time
Role Summary
The Study Start-Up Submissions Manager will be responsible for managing end-to-end clinical trial start-up and regulatory submission activities in India and across the APAC region. The role focuses on ensuring timely regulatory approvals, effective stakeholder coordination, and compliance with local and regional regulatory requirements, particularly with DCGI/CDSCO processes.
Key Responsibilities
1. Regulatory Submissions & Approvals
Track and follow up on clinical trial submissions with the Drugs Controller General of India (DCGI)
Manage regulatory interactions with DCGI and other authorities
Ensure timely responses and resolution of regulatory queries
Review relevant regulations to proactively address start-up challenges
2. Clinical Trial Start-Up Management
Execute end-to-end site activation and study start-up activities across India and APAC
Coordinate regulatory, ethics, and site activation timelines
Ensure smooth initiation of clinical trials in alignment with study plans
3. Stakeholder Coordination
Independently communicate with:
Sponsors
Clinical trial sites
Institutional Review Boards (IRBs) / Ethics Committees (ECs)
Regulatory authorities (CDSCO, DCGI)
Facilitate meetings and consultations with regulatory bodies as required
4. Document Review & Quality Assurance
Perform quality checks on regulatory submission packages
Review site essential documents for compliance and completeness
Prepare and approve informed consent forms (ICFs)
5. Client & Internal Representation
Participate in bid defenses and capability presentations
Support audits and regulatory inspections
Represent start-up operations in internal and external meetings
Required Qualifications
Bachelor’s degree (Life Sciences, Pharmacy, Medicine, or related field preferred)
Minimum 8+ years of experience in regulatory submissions or clinical research
Experience with CRO environments preferred
Prior experience as CRA or Project Manager is acceptable
Required Experience & Skills
Strong hands-on experience with:
Regulatory submissions to Ethics Committees (EC) and Regulatory Authorities (RA)
CDSCO / DCGI submission processes
Strong understanding of clinical trial regulations in India
Excellent oral and written communication skills
Ability to independently manage regulatory interactions and submissions
Experience in preparing, reviewing, and responding to regulatory queries
Strong organizational and problem-solving abilities in start-up environments
Level Expectations
RSC Level: Strong local India regulatory experience required
RSM Level: Local + APAC regional regulatory experience required
About the Organization
Medpace is a full-service global clinical contract research organization (CRO) supporting Phase I–IV clinical development across therapeutic areas such as oncology, cardiology, metabolic disease, endocrinology, CNS disorders, and infectious diseases.
The company operates across 40+ countries with a strong focus on accelerating safe and effective medical product development through disciplined clinical research execution.
Benefits & Work Environment
Flexible remote work structure
Competitive compensation and benefits
Structured career progression pathways
Employee wellness initiatives
Global exposure through international clinical programs
Recognition as a leading CRO in industry awards and rankings
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Remote, India | Siliguri |Illinois :
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Argentina | Peru |Brazil :
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Tallinn |Hà Nội :
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