Medpace is a full-service Clinical Research Organization (CRO) committed to accelerating the global development of safe and effective medical therapeutics. Founded over 30 years ago, Medpace collaborates with biotechnology, pharmaceutical, and medical device industries to conduct Phase I-IV clinical trials. With headquarters in Cincinnati, Ohio, we operate in over 40 countries and employ more than 5,000 experts. Our dynamic work environment focuses on delivering exceptional results that make a meaningful impact on patients’ lives.
Job Details
Company: Medpace
Location: Navi Mumbai, India
Salary: ₹4 – 5 Lacs per year
Experience: 1 Year
Education Requirements: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Job Type: Full-time
Application: Apply Online
Position Overview: Study Start-up Submissions Coordinator
We are currently seeking a Study Start-up Submissions Coordinator to join our Clinical Operations team in Navi Mumbai, India. This vital role focuses on the activation of clinical trial sites, ensuring that regulatory submissions align with both local and global compliance standards.
Key Responsibilities
- Oversee the activation of investigative sites for clinical trials at all stages.
- Prepare, review, and submit essential documents to Ethics Committees and Regulatory Authorities.
- Communicate with global study teams to report progress and provide updates.
- Identify risks to site activation and implement effective solutions.
- Offer guidance to global teams on regulatory submissions and compliance.
- Maintain direct communication with investigative sites throughout the start-up and activation phases.
- Ensure compliance with regulatory standards such as ICH-GCP guidelines.
- Provide advisory support to sponsors on regulatory changes.
- Monitor submission timelines and track documentation to ensure deadlines are met.
Qualifications
| Requirement | Details |
|---|---|
| Education | Bachelor’s degree in a science-related field or equivalent mix of education and experience. |
| Experience | At least 1 year working with a CRO, pharmaceutical company, or investigative site. |
| Document Submission | Hands-on experience in preparing and submitting documents to Ethics Committees and Regulatory Agencies. |
| Technical Skills | Proficiency in Microsoft Office tools. |
| Regulatory Knowledge | Solid understanding of ICH-GCP guidelines and regulatory requirements. |
| Communication Skills | Strong communication and organizational skills, ability to write responses to regulatory queries. |
| Language | Fluency in English is required. |
Skills You Need to Succeed
- Attention to Detail: Ensure error-free submissions.
- Project Management: Handle multiple submissions simultaneously.
- Collaboration: Work effectively with global teams and investigative sites.
- Problem-Solving: Address and resolve risks during site activation.
- Adaptability: Navigate changing regulatory landscapes.
Work Environment
Medpace offers a hybrid work environment that promotes work-life balance, along with exciting projects and career growth opportunities.
Join Medpace and contribute to the development of medical therapeutics that impact patients’ lives!
Apply Now