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Medpace · 5 hours ago

Study Start-Up Project Manager

Denver, CO

Full-time

Onsite

Senior Level, Lead/Staff

$100K/yr - $165K/yr

5+ years exp

Medpace is a full-service clinical contract research organization (CRO) seeking a Global Study Start-Up Project Manager to join their Clinical Operations team. This role is crucial for managing the execution of global start-up studies, leading teams, and ensuring compliance with regulatory submissions.

BiotechnologyPharmaceutical

Responsibilities

Efficiently manage successful execution of global start-up, maintenance, and close-out studies

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

Contribute to the growth and development of departmental staff, processes and systems

Qualification

Clinical research experienceLife Sciences degreeProject managementCardiovascular experienceMetabolic indications experienceCommunication skills

Required

Bachelor's degree required

5+ years of experience in clinical research, preferably in a Senior/Lead role at a CRO in Study Start-Up

Project management experience and demonstrated role in developing others

Strong oral and written communication skills required

Preferred

Advanced degree in Life Sciences preferred

Experience with Cardiovascular and Metabolic indications in an academic and/or clinical trial setting is desired, such as, but not limited to, NASH, diabetes, medical devices and coronary artery diseases