Instagram
youtube
Facebook

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 (India)

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 is critical to site activation and plays a key part in the successful execution of clinical trials. If you are looking for a challenging and rewarding career where you can apply your expertise and grow further, this opportunity is for you.

Responsibilities:

  • Manage country-specific activities to ensure site activation for clinical trials across all phases.
  • Prepare, review, and submit regulatory documents to Regulatory Agencies and Ethics Committees (ECs).
  • Communicate with global study teams and provide updates on study progress.
  • Identify and mitigate risks related to site activation.
  • Advise and guide study teams on regulatory and ethical submission requirements.
  • Review and finalize essential site documents for activation.
  • Serve as the primary contact for submission-related activities.
  • Ensure regulatory compliance and keep sponsors informed on changing regulations.
  • Track submissions and maintain timely document filings.

Qualifications:

  • Bachelor’s degree in a scientific field or equivalent experience.
  • At least 4 years of relevant experience in a CRO, pharmaceutical company, or investigative site.
  • Proficiency in Microsoft Office and strong organizational skills.
  • Knowledge of ICH-GCP and regulatory guidelines.
  • Hands-on experience with regulatory submissions and responding to queries.
  • Strong English communication skills (verbal & written).

Why Join Medpace?

  • Flexible work environment with career growth opportunities.
  • Competitive salary, benefits, and PTO packages.
  • 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 global clinical contract research organization (CRO) that provides Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, Medpace has a presence in 40+ countries with 5,000+ employees worldwide.