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Medpace · 1 week ago

Study Start-Up Project Manager

United States

Full-time

Remote

Senior Level, Lead/Staff

5+ years exp

Medpace is a full-service clinical contract research organization (CRO) that provides clinical development services to the biotechnology, pharmaceutical, and medical device industries. They are seeking a Global Study Start-Up Project Manager to efficiently manage the execution of global start-up studies and lead others in a matrix environment, while also serving as a point of contact for 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 experienceProject management experienceLeadership skillsBachelor's degreeAdvanced degree in Life SciencesOral communication skillsWritten communication skills