Senior Study Start-Up Project Manager

About the Role: Senior Study Start-Up Project Manager at Medpace

Do you thrive in a fast-paced environment, empowered to make strategic decisions, and contribute to a growing, profitable company? Medpace is rapidly expanding its clinical operations activities and is seeking a full-time, Global Senior Study Start-Up Project Manager to join its Clinical Operations team. This pivotal role is central to the clinical trial management process at Medpace.

Incentives for this role include a competitive bonus program, a sign-on bonus, and equity awards.

Location: Remote

Key Responsibilities

• Efficiently manage the successful execution of global study start-up, maintenance, and close-out activities.
• Effectively lead cross-functional teams within a matrix environment.
• Perform meticulous quality checks on submission documents and site essential documents.
• Prepare and approve informed consent forms, ensuring compliance and clarity.
• Serve as the primary Sponsor point of contact for all start-up and regulatory submission items.
• Review pertinent regulations to proactively develop innovative solutions for start-up challenges.
• Prepare new business proposals and actively participate in bid defenses, general capabilities meetings, and audits.
• Contribute significantly to the growth and professional development of departmental staff, processes, and systems.

Qualifications

• A Bachelor's degree is required; an advanced degree in Life Sciences is preferred.
• Candidates must have 5+ years of experience in clinical research, with a strong preference for experience in a Senior/Lead role at a Contract Research Organization (CRO) specifically within Study Start-Up.
• Demonstrated project management experience, with a proven track record in developing and mentoring others.
• Exceptional oral and written communication skills are essential for this role.

Travel: Minimal

Medpace Overview

Medpace is a comprehensive full-service clinical contract research organization (CRO) dedicated to accelerating the global development of safe and effective medical therapeutics. We offer Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Leveraging local regulatory and therapeutic expertise, Medpace covers major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs over 5,000 professionals across 40+ countries.

Why Medpace?

At Medpace, it's about People, Purpose, and Passion. Join us today to make a difference tomorrow. For over 30 years, our work has positively impacted countless patients and families facing a multitude of diseases. The contributions made today will continue to improve lives in the future.

Medpace Perks

• Flexible work environment
• Competitive Paid Time Off (PTO) packages, starting at 20+ days
• Company-sponsored employee appreciation events
• Comprehensive employee health and wellness initiatives
• Competitive compensation and benefits package
• Structured career paths with abundant opportunities for professional growth
• Discounts for local businesses

Awards & Recognition

• Named a Top Workplace in 2024 by The Cincinnati Enquirer.
• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024.
• Continually honored with CRO Leadership Awards from Life Science Leader magazine for expertise, quality, capabilities, reliability, and compatibility.

What To Expect Next: A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Key skills/competency

• Project Management
• Clinical Research
• Regulatory Submissions
• Study Start-Up
• ICH-GCP
• Site Management
• CRO Operations
• Leadership
• Quality Assurance
• Clinical Operations