Are you ready to advance your career in clinical research? Medpace, a global leader in clinical trial services, is looking for a Study Start-Up Submissions Coordinator to join their Clinical Operations team in Navi Mumbai. This role offers a chance to contribute to meaningful projects that drive success and innovation in clinical development.
About Medpace
Medpace is a leading full-service clinical contract research organization (CRO), specializing in Phase I-IV clinical development services across major therapeutic areas such as oncology, cardiology, and central nervous system disorders. Headquartered in Cincinnati, Ohio, Medpace operates in over 40 countries with a team of more than 5,000 professionals. Their mission is to accelerate the global development of safe and effective medical therapeutics through a disciplined and scientific approach.
Key Responsibilities
As a Study Start-Up Submissions Coordinator, your role will be pivotal in activating investigative sites for clinical trials. Your responsibilities will include:
- Preparing, reviewing, and submitting documents to regulatory agencies and ethics committees.
- Coordinating with global study teams to track and report study progress.
- Identifying potential risks in site activations and implementing mitigation strategies.
- Providing expertise and guidance on ethics and regulatory submissions.
- Acting as the primary contact for submission-related activities during study initiation.
- Ensuring compliance with ICH-GCP guidelines, regulatory standards, and internal policies.
- Advising sponsors on evolving regulations and compliance requirements.
- Directly communicating with investigative sites throughout the activation process.
Qualifications and Skills
To succeed in this role, Medpace requires the following qualifications:
Educational Background
- A Bachelor’s degree in science or an equivalent combination of education and experience.
Professional Experience
- At least 1 year of experience at a CRO, pharmaceutical company, or investigative site.
- Hands-on expertise in preparing and submitting regulatory documentation.
Core Skills
- Strong organizational and communication abilities.
- Proficiency in Microsoft Office tools.
- Solid understanding of ICH-GCP and regulatory guidelines.
- Fluency in English, both written and verbal.
Why Join Medpace?
At Medpace, you’ll find a collaborative and rewarding work environment that fosters professional growth and innovation.
Perks and Benefits
- Flexible work environment.
- Competitive compensation and PTO packages.
- Structured career development paths.
- Company-sponsored appreciation events.
- Employee health and wellness initiatives.
Recognition
- Featured in Forbes as one of America’s Most Successful Midsize Companies (2021–2024).
- Consistently awarded CRO Leadership Awards by Life Science Leader magazine.
