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Study Start Up Submissions Manager (Remote Based In Delhi)

8+ years
Not Disclosed
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.