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. Activate Investigative Sites:
   • Perform activities leading to the activation of investigative sites in all phases of clinical trials.
2. Regulatory Submissions:
   • Prepare, review, and submit regulatory documents to Regulatory Agencies.
3. Global Communication:
   • Communicate with global study teams and personnel on study progress.
4. Risk Identification and Mitigation:
   • Effectively identify risks to site activations and mitigate as necessary.
5. Ethics and Regulatory Guidance:
   • Provide expertise and guidance to global study teams in ethics and regulatory submissions.
6. Essential Document Review:
   • Review and finalize essential documents required for site activation.
7. Main Contact for Submissions:
   • Act as the main contact for Ethical and Regulatory submission-related activities.
8. Site Interaction:
   • Direct contact with investigative sites during the study start-up and activation process.
9. Regulatory Compliance:
   • Ensure submissions comply with applicable regulations and guidance documents.
10. Regulatory Advisory:
    • Advise sponsors on changing regulations and compliance requirements.
11. Submission Tracking:
    • Track submissions and ensure timely filing of documents.

Qualifications

• Bachelor’s degree and more than 8 years of regulatory submissions experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
• Strong Local experience mandatory for RSC level, Local and Regional APAC experience mandatory for RSM level
• Strong oral and written communication skills.
• Hands-on experience preparing, reviewing, and submitting regulatory documentation to EC and RA; including formulating responses to queries

How to Apply

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

Apply online

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