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Study Start Up Submissions Manager

Medpace

8+ years

Not Disclosed

Navi Mumbai

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 – Navi Mumbai, India

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

Job Summary:

Medpace is seeking a full-time Study Start-Up Submissions Manager to join its Clinical Operations team in Mumbai. This role involves overseeing local and global regulatory submissions, ensuring compliance with regulatory authorities, and interacting with Sponsors, IRBs, Ethics Committees, and regulatory agencies (DCGI minimum).

Responsibilities:

Efficiently manage and execute all aspects of study start-up at local and global levels.
Independently interact with Sponsors, sites, IRBs/ECs, and regulatory agencies.
Conduct quality checks on submission documents and site essential documents.
Prepare and approve informed consent forms.
Review regulations and proactively solve start-up issues.
Represent Medpace during bid defenses, capability meetings, and audits.

Qualifications:

Bachelor’s degree with 8+ years of regulatory submissions experience in clinical research (preferably in a CRO).
Experience in CRA or project management is a plus.
Local and regional regulatory experience is highly preferred.
Strong oral and written communication skills.

Why Join Medpace?

Flexible work environment.
Competitive salary, benefits, and PTO packages.
Career growth opportunities with structured development paths.
Company-sponsored appreciation events and wellness initiatives.
Recognized as one of America's Most Successful Midsize Companies (Forbes, 2021-2024).

About Medpace:

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

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Study Start Up Submissions Manager

Job Description

Job Summary:

Responsibilities:

Qualifications:

Why Join Medpace?

About Medpace:

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