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- Study Start-Up Project Manager – Rare Disease
Study Start-Up Project Manager – Rare Disease
Medpace Holdings, Inc.
United States, OH, Cincinnati | United States, TX, Irving (Dallas) | United States, CO, Denver
Job Summary
Do you enjoy working in a fast-paced environment where you are empowered to make strategic decisions and contribute to a growing and profitable company? Are you tired of voicing ideas that go unheard? Join us at Medpace! Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Senior Global Study Start-Up Lead to join our Clinical Operations team. This position plays a key role inthe clinical trial managementprocess at Medpace.
Incentives can include: Competitive bonus program, sign-on/relocation bonus, and equity awards.
Location: Position can be office based in Cincinnati, Dallas or Denver.
#remote.
Responsibilities
- Efficiently manage successful execution of global start-up, maintenance, and close-out;
- Effectively lead others in a matrix environment;
- Perform quality checks on submission documents and site essential documents;
- Prepare and approve informed consent forms;
- Serve as a Sponsor point of contact for start-up and regulatory submissions items;
- Review pertinent regulations to develop proactive solutions to start-up challenges;
- Prepare new business proposals and present during bid defenses, general capabilities meetings, and audits; and
- Contribute to the growth and development of departmental staff, processes, and systems.
Qualifications
- Bachelor's degree required, advanced degree in Life Sciences preferred
- 5+ years of experience in clinical research, preferably in a Senior/Lead role at a CRO in Study Start-Up
- Experience in the area of rare diseases for clinical trials, e.g., Duchenne Muscular Dystrophy, Epilepsy, Cystic Fibrosis, Amyotrophic Lateral Sclerosis (Lou Gehrig’s), etc.
- Project management experience and demonstrated role in developing others
- Strong oral and written communication skills required
Travel: Minimal
Job posted: 2024-01-05