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Experienced Study Start Up Submissions Coordinator

4+ 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

Experienced Study Start-Up Submissions Coordinator

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

Job Summary:

Medpace is seeking an Experienced Study Start-Up Submissions Coordinator to join its Clinical Operations team in India. This role involves regulatory submissions, site activation, and communication with global study teams to ensure compliance and efficiency in clinical trials.

Responsibilities:

  • Lead site activation for all phases of clinical trials within the country.
  • Prepare, review, and submit regulatory documents to Ethics Committees and Regulatory Agencies.
  • Communicate with global study teams to track study progress and site activations.
  • Identify and mitigate risks related to site activation.
  • Advise sponsors on regulatory changes and compliance requirements.
  • Act as the main contact for ethics and regulatory submission activities.
  • Ensure timely filing and tracking of regulatory submissions.

Qualifications:

  • Bachelor’s degree in a science-related field (or equivalent experience).
  • At least 4 years of relevant experience in a CRO, pharmaceutical company, or investigative site.
  • Proficiency in Microsoft Office and knowledge of ICH-GCP guidelines and regulatory requirements.
  • Experience preparing, reviewing, and submitting regulatory documentation with the ability to address queries.
  • Strong organizational and communication skills with a good command of English.

Why Join Medpace?

  • Flexible work environment with structured career growth.
  • Competitive compensation and PTO packages.
  • Comprehensive benefits and employee wellness initiatives.
  • Company-sponsored appreciation events.
  • Recognized as one of America’s Most Successful Midsize Companies (2021-2024) by Forbes.

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 employs 5,000+ professionals in 40+ countries.