Senior Study Start up Submissions Coordinator (Remote based in Delhi)

Senior Study Start up Submissions Coordinator (Remote based in Delhi)

Join Medpace, a leading full-service clinical contract research organization (CRO), on a journey of scientific discovery and disciplined development of medical therapeutics. With a global presence across 40+ countries, Medpace is dedicated to accelerating the development of safe and effective medical solutions. If you are passionate about clinical research and seeking an opportunity to grow your career, Medpace is the place for you.

Medpace Vacancies List

Position Title: Study Start up Submissions Coordinator

currently seeking a full-time, remote-based Senior Study Start up Submissions Coordinator to join our Clinical Operations team in India, Delhi.

Department: Clinical Operations

Job Type: Full-Time

Job Description

As a Study Start up Submissions Coordinator at Medpace, you will be an essential part of our Clinical Operations team in Mumbai, India. Your role involves performing critical activities within the country to activate investigative sites for clinical trials. If you thrive in a dynamic environment, excel at problem-solving, and are committed to supporting business partners, this is the opportunity you’ve been waiting for.

Responsibilities

1. Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
2. Prepare, review, and submit to Regulatory Agencies;
3. Communicate with global study teams and personnel on study progress;
4. Ability to effectively identify risks to site activations and mitigate as necessary;
5. Provide expertise and guidance to global study teams in ethics and regulatory submissions;
6. Review and finalize essential documents required for site activation;
7. Act as a main contact for Ethical and Regulatory submission-related activities;
8. Direct contact with investigative sites during the study start up and activation process;
9. Ensure submissions comply with applicable regulations and guidance documents;
10. Advise sponsors on changing regulations and compliance requirements; and
11. Track submissions and ensure timely filing of documents.

Qualifications

• Bachelor’s degree in the science field or equivalent combination of education and experience;
• At least 4 years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
• Excellent organization and communication skills;
• Knowledge of Microsoft® Office,ICH – GCP guidelines andregulatory guidelines;
• Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and
• Good command in English.

How to Apply

To apply for the position of Study Start up Submissions Coordinator at Medpace.

Apply online

Important Information (In Tabular Form)