Experienced Study Start-Up Submissions Coordinator
Location: Navi Mumbai, India
Department: Site Activation & Maintenance
Job ID: 10930
Job Summary:
Medpace is seeking a full-time, office-based Experienced Study Start-Up Submissions Coordinator to join its Clinical Operations team in Mumbai. This pivotal role supports the successful activation of investigative sites across all phases of clinical trials. Candidates will have the opportunity to apply their regulatory expertise while advancing their careers in a dynamic and empowering work environment.
Responsibilities:
Execute tasks required for the activation of investigative sites for clinical trials.
Prepare, review, and submit documentation to Regulatory Agencies.
Coordinate with global study teams to report study progress.
Identify potential risks to site activations and implement mitigation strategies.
Provide guidance to global teams on ethics and regulatory submissions.
Finalize essential documents for site activation.
Serve as the main contact for ethical and regulatory submission processes.
Liaise directly with investigative sites during the start-up and activation phases.
Ensure all submissions are compliant with applicable regulations and guidance.
Advise sponsors on regulatory changes and compliance requirements.
Track and manage submission documentation to ensure timely filing.
Qualifications:
Bachelor’s degree in a scientific discipline or equivalent combination of education and experience.
Minimum of 4 years of relevant experience in a CRO, pharmaceutical company, or investigative site.
Proficiency in Microsoft Office.
Strong knowledge of ICH-GCP and regulatory guidelines.
Demonstrated experience with regulatory documentation and ethical committee submissions.
Excellent organizational, communication, and English language skills.
About Medpace:
Medpace is a full-service clinical CRO offering Phase I-IV development services to the pharmaceutical, biotechnology, and medical device industries. Headquartered in Cincinnati, Ohio, Medpace operates in over 40 countries with a mission to accelerate the development of effective medical therapies through scientific rigor and operational excellence.
Why Join Medpace?
Flexible work environment
Competitive compensation and benefits
Generous PTO policy
Clear, structured career development paths
Employee recognition and appreciation events
Health and wellness programs
Awards and Recognition:
Featured in Forbes: America’s Most Successful Midsize Companies (2021–2024)
Multiple CRO Leadership Awards by Life Science Leader magazine
Next Steps:
Selected candidates will be contacted by a Medpace team member with further details.
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