Study Start-Up Submissions Manager (Remote – Delhi)
Location: Remote (based in Delhi), India
Job Description:
Medpace is seeking a highly skilled Study Start-Up Submissions Manager to join our Clinical Operations team. This is a full-time, remote-based role focused on managing submissions to regulatory authorities and ethics committees, with specific expertise in DCGI processes and APAC regional regulations. You’ll play a pivotal role in driving efficient and compliant clinical trial start-up activities across India and Asia-Pacific.
Key Responsibilities:
Provide close follow-up on Clinical Trial submissions to the Drugs Controller General of India (DCGI), including face-to-face visits when required.
Coordinate and facilitate meetings with DCGI, offering support during consultation processes.
Manage and execute local and regional APAC clinical trial start-up activities efficiently and independently.
Liaise with Sponsors, clinical sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs), and regulatory authorities (including CDSCO and DCGI).
Conduct quality checks on submission and essential site documents to ensure accuracy and completeness.
Prepare and review Informed Consent Forms (ICFs) for ethical and regulatory compliance.
Analyze and apply relevant regulations to proactively resolve start-up issues and regulatory challenges.
Represent Medpace during bid defenses, client capabilities presentations, and audits.
Qualifications:
Bachelor’s degree in life sciences or a related discipline.
8+ years of experience in regulatory submissions for clinical research, preferably within a CRO environment.
Strong local regulatory experience is mandatory; regional APAC experience preferred for higher responsibility roles.
Proven track record in preparing, submitting, and responding to EC and RA documentation.
Excellent verbal and written communication skills.
Hands-on experience interacting with regulatory bodies, particularly DCGI and CDSCO.
Why Join Medpace?
Remote-based flexibility
Competitive salary and benefits
Structured growth and career development paths
Employee appreciation programs and wellness initiatives
Involved in cutting-edge therapeutic areas across all phases of development
About Medpace:
Medpace is a global clinical contract research organization (CRO) providing Phase I–IV development services across all major therapeutic areas. Headquartered in Cincinnati, Ohio, and present in over 40 countries with 5,000+ employees, Medpace delivers comprehensive drug, biologic, and medical device development solutions.
Awards & Recognition:
Named by Forbes as one of America's Most Successful Midsize Companies (2021–2024)
Winner of multiple CRO Leadership Awards for expertise, quality, and reliability
Estimated Salary: ₹14 – ₹20 LPA (based on experience and regional market standards)
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Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
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Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
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