Study Start Up Submissions Manager (Remote Based In Delhi)

Medpace

8+ years

Not Disclosed

India

10 March 6, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Study Start-up Submissions Manager (Remote - Delhi)

Employer: Medpace
Industry: Clinical Research (CRO)
Department: Site Activation & Maintenance
Employment Type: Full-Time
Location: Remote (Delhi, India)

Job Summary:

Medpace is seeking a Study Start-up Submissions Manager to join its Clinical Operations team in India. This remote-based role involves managing regulatory submissions for clinical trials, ensuring compliance with local and regional regulations, and collaborating with regulatory authorities, ethics committees, and sponsors.

Responsibilities:

Monitor clinical trial submissions to the Drugs Controller General of India (DCGI) with face-to-face follow-ups.
Facilitate meetings with DCGI and support consultation processes.
Manage and execute local and regional APAC start-up processes.
Liaise 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.
Review regulatory requirements and provide proactive solutions to start-up challenges.
Present during bid defenses, capability meetings, and audits.

Qualifications:

Bachelor’s degree with 8+ years of regulatory submissions experience in clinical research (CRO experience preferred).
Experience in CRA or project management is advantageous.
Local experience required for RSC level; Local & Regional APAC experience required for RSM level.
Strong oral and written communication skills.
Hands-on experience in regulatory documentation submission to EC and RA, including query responses.

Why Join Medpace?

Flexible work environment.
Competitive compensation, benefits, and PTO packages.
Employee wellness programs and structured career growth.
Company-sponsored appreciation events.
Recognized by Forbes as one of America's Most Successful Midsize Companies (2021-2024).

About Medpace:

Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to biotech, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, Medpace operates in 40+ countries with 5,000+ professionals worldwide.

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Study Start Up Submissions Manager (Remote Based In Delhi)

Job Description

Job Summary:

Responsibilities:

Qualifications:

Why Join Medpace?

About Medpace:

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