Medpace BSc Study Start up Submissions Coordinator Role – Apply Now
Study Start-Up Submissions Coordinator
Navi Mumbai, India
Site Activation & Maintenance
Job ID: 10278
Job Summary
We are currently seeking a full-time, office-based Study Start-Up Submissions Coordinator to join our Clinical Operations team in the Mumbai, India office. This role is essential to the team, handling tasks and projects that are crucial to the company’s success. If you’re looking for an exciting career where you can leverage your expertise while developing and advancing your career, this is the opportunity for you.
Our culture fosters expertise, empowering our teams to apply their unique skills and experience in research, problem-solving, and supporting our business partners. At Medpace, our employees embody our values, embracing high expectations and rising to challenges. In return, they are rewarded with engaging projects, career growth, and recognition within our global network. These are just a few reasons why talented individuals join the Medpace team.
Responsibilities
- Perform required activities within the country to activate investigative sites in all phases of clinical trials
- Prepare, review, and submit documentation to Regulatory Agencies
- Communicate study progress with global study teams and personnel
- Identify and mitigate risks to site activations effectively
- Provide expertise and guidance to global study teams on ethics and regulatory submissions
- Review and finalize essential documents needed for site activation
- Serve as the main contact for Ethical and Regulatory submission-related activities
- Maintain direct contact with investigative sites during the study start-up and activation process
- Ensure submissions adhere to applicable regulations and guidance documents
- Advise sponsors on evolving regulations and compliance requirements
- Track submissions to ensure timely document filing
Qualifications
- Bachelor’s degree in a science field or an equivalent combination of education and experience
- At least one year of relevant experience in a CRO, Pharmaceutical Company, or an investigative site
- Excellent organizational and communication skills
- Proficiency with Microsoft® Office
- Knowledge of ICH-GCP guidelines and regulatory guidelines
- Hands-on experience in preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies, including formulating responses to queries
- Strong command of English
Keywords: Study Start up Submissions Coordinator, Study Start up Coordinator job, Navi Mumbai, Clinical Operations, Regulatory submissions, Clinical trials, Pharmaceutical industry. Medpace BSc Study Start up Submissions Coordinator Role – Apply Now. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
