Experienced Study Start-Up Project Manager (Remote)

Medpace is a full-service clinical contract research organization providing clinical development services to the biotechnology, pharmaceutical, and medical device industries. The Global Study Start-Up Project Manager will manage global study start-up, maintenance, and close-out activities, lead teams in a matrix environment, oversee regulatory and essential document processes, and support proposals, audits, and departmental development.

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

Requirements:

• Bachelor's degree required, advanced degree in Life Sciences preferred
• 4+ years of direct CRO experience within a Senior/Lead role required
• Study Start-Up/Activation project management experience required
• Strong oral and written communication skills required