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Senior Study Start Up Submissions Coordinator (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

Senior Study Start-Up Submissions Coordinator (Remote – Delhi)

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

Job Summary:

Medpace is seeking a Senior Study Start-Up Submissions Coordinator to join its Clinical Operations team remotely in Delhi, India. This role involves managing regulatory submissions, facilitating meetings with Drugs Controller General of India (DCGI), and ensuring compliance with regional and local regulations for clinical trials.

Responsibilities:

  • Monitor and follow up on clinical trial submissions to DCGI, including in-person visits.
  • Facilitate meetings with DCGI and support consultation processes as needed.
  • Oversee local and regional APAC study start-up activities and ensure timely execution.
  • Independently liaise with sponsors, sites, IRBs/ECs, and regulatory agencies (minimum CDSCO and DCGI).
  • Conduct quality checks on submission documents and site essential documents.
  • Prepare and approve informed consent forms to ensure regulatory compliance.
  • Review regulations proactively to resolve start-up issues and challenges.
  • Participate in bid defenses, capability meetings, and audits to support business development.

Qualifications:

  • Bachelor’s degree with 8+ years of regulatory submissions experience in clinical research (preferably in a CRO).
  • Experience in Clinical Research Associate (CRA) or project management roles is an advantage.
  • Strong knowledge of local regulations (mandatory for RSC level) and regional APAC regulatory experience (mandatory for RSM level).
  • Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees (EC) and Regulatory Agencies (RA).
  • Excellent written and verbal communication skills in English.

Why Join Medpace?

  • Flexible remote work environment with structured career growth.
  • Competitive compensation and benefits package.
  • Comprehensive PTO 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.