Job Title: Study Start up Submissions Coordinator
Company: Medpace
Location: Navi Mumbai, India
Department: Site Activation & Maintenance
Job ID: 11032
Job Summary:
Medpace is seeking a full-time, office-based Study Start up Submissions Coordinator to join its Clinical Operations team in Navi Mumbai. This position plays a pivotal role in facilitating the activation of investigative sites for clinical trials across various phases. The role is suited for professionals aiming to contribute their expertise while growing within a supportive, international environment.
Key Responsibilities:
Oversee and perform country-specific activities required for site activation in clinical trials.
Prepare, review, and submit documentation to regulatory agencies.
Liaise with global study teams and stakeholders to monitor study progress.
Identify and mitigate risks associated with site activations.
Guide study teams on ethical and regulatory submissions.
Review and finalize essential documents necessary for site activation.
Serve as the primary contact for ethics and regulatory submission activities.
Maintain direct communication with investigative sites during start-up phases.
Ensure submission processes comply with current regulatory guidelines.
Advise sponsors on updated regulations and compliance standards.
Track and ensure timely filing of all submission documents.
Qualifications:
Bachelor’s degree in a scientific discipline or equivalent combination of education and experience.
Minimum 1 year of relevant experience in a CRO, pharmaceutical company, or investigative site.
Proficient in Microsoft Office and knowledgeable in ICH-GCP and regulatory guidelines.
Experience with ethics and regulatory documentation preparation, submission, and query responses.
Strong organizational and communication skills.
Good command of English.
About Medpace:
Medpace is a global, full-service clinical contract research organization (CRO) specializing in Phase I–IV clinical development. With headquarters in Cincinnati, Ohio, and over 5,000 employees across more than 40 countries, Medpace partners with the biotechnology, pharmaceutical, and medical device industries to deliver safe and effective medical therapeutics through scientific rigor and regulatory expertise.
Why Join Medpace?
Flexible work environment
Competitive salary and benefits
Generous PTO structure
Defined career development opportunities
Health and wellness initiatives
Recognition through employee appreciation events
Awards & Recognition:
Recognized by Forbes as one of America’s Most Successful Midsize Companies (2021–2024)
Consistently honored with CRO Leadership Awards from Life Science Leader magazine
What Happens Next:
Qualified candidates will be contacted by a Medpace team member to discuss the next steps in the recruitment process.
EO/AA Employer: M/F/Disability/Vets
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