Medpace is looking for a full-time, office-based Study Start-up Submissions Coordinator to join their Clinical Operations team in Mumbai. This role supports the activation of investigative sites across all phases of clinical trials and ensures successful submissions to regulatory bodies.
Responsibilities:
- Site Activation: Perform activities that lead to the activation of investigative sites for clinical trials.
- Regulatory Submissions: Prepare, review, and submit documentation to Regulatory Agencies.
- Global Communication: Liaise with global study teams and personnel on the progress of studies.
- Risk Mitigation: Identify risks related to site activations and implement mitigation strategies.
- Ethics & Regulatory Guidance: Provide expert guidance to global study teams on ethical and regulatory submissions.
- Document Review: Finalize essential documents required for site activation.
- Main Contact: Serve as the primary contact for ethical and regulatory submission-related activities.
- Regulatory Compliance: Ensure submissions comply with relevant regulations and advise sponsors on changing compliance requirements.
- Documentation Tracking: Track submissions and ensure the timely filing of required documents.
Qualifications:
- Education: Bachelor’s degree in a science-related field or equivalent education and experience.
- Experience: At least 1 year of relevant experience in a CRO, Pharmaceutical Company, or investigative site.
- Skills:
- Excellent organizational and communication skills.
- Knowledge of Microsoft® Office.
- Understanding of ICH-GCP and regulatory guidelines.
- Hands-on experience preparing, reviewing, and submitting regulatory documents to Ethics Committees and Regulatory Agencies, including handling queries.
- Language: Proficiency in English.
