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Study Start Up Submissions Manager

8+ years
Not Disclosed
10 Dec. 20, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Opening: Study Start-up Submissions Manager

Location: Navi Mumbai, India
Department: Site Activation & Maintenance
Job ID: 9422
Job Type: Full-Time, Office-Based

Job Summary:
We are seeking a Study Start-up Submissions Manager to join our Clinical Operations team in Navi Mumbai, India. This full-time, office-based role will be key in managing and executing all aspects of local and global start-up activities for clinical studies.

Responsibilities:

  • Efficiently manage and execute all aspects of local and global start-up activities.
  • Independently interact with Sponsors, sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs), and regulatory agencies (e.g., DCGI).
  • Perform quality checks on submission documents and site essential documents.
  • Prepare and approve informed consent forms.
  • Review regulations to proactively address start-up issues and challenges.
  • Participate in bid defenses, general capabilities meetings, and audits.

Qualifications:

  • Bachelor’s degree with over 8 years of regulatory submissions experience in clinical research, ideally with a CRO. Experience may include CRA or project management roles.
  • Local and regional experience is highly advantageous.
  • Strong oral and written communication skills.

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. With over 5,000 employees across 40+ countries, Medpace is headquartered in Cincinnati, Ohio and is dedicated to accelerating the development of safe and effective therapeutics.

Why Medpace?

  • People. Purpose. Passion. Make a difference today to improve lives tomorrow.
  • Recognized by Forbes as one of America’s Most Successful Midsize Companies (2021, 2022, 2023, 2024).
  • Awarded CRO Leadership Awards for expertise, quality, capabilities, reliability, and compatibility.

Medpace Perks:

  • Flexible work environment
  • Competitive compensation and benefits package
  • Competitive PTO packages
  • Structured career paths with opportunities for professional growth
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives

How to Apply:
If you are an experienced Study Start-up Submissions Manager with a passion for clinical operations, apply today to join Medpace!