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Medpace · 17 hours ago

Study Start-Up Project Manager (Denver)

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. The role involves managing the execution of global start-up studies and leading a team in a matrix environment while ensuring compliance with regulatory requirements.

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 experienceCardiovascularMetabolic knowledgeProject managementLife Sciences degreeOral communicationWritten communication

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