Study Start-Up Project Manager

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. When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Job Summary:

Do you enjoy working in a fast-paced environment where you are empowered to make strategic decisions and contribute to a growing and profitable company? Join us at Medpace! Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Global Study Start-Up Project Manager to join our Clinical Operations team. This position plays a key role in the clinical trial management process at Medpace. 

 

Incentives can include: Competitive bonus program, sign-on/relocation bonus, and equity awards.

 

Location: Position is office based in Cincinnati, OH.

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.

Qualifications :

• Bachelor's degree required, 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.
• 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

Travel: Minimal

Medpace Overview :

Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?:

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

 

Purpose-Driven Work

• • Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

 

Collaborative Culture

• • Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
  • Leadership throughout Medpace is both accessible and approachable

 

Continuous Growth & Development

• • Office based environment with on-site mentors
  • Defined career paths with clear advancement opportunities
  • Industry renowned onboarding and training programs designed to accelerate professional development
  • Ongoing training and continuous learning opportunities throughout your career
  • An environment that encourages employees to influence change, contribute ideas, and grow quickly

 

Other Employee Benefits

• • Competitive compensation programs that recognize and reward performance
  • Comprehensive health, wellness, retirement, and PTO benefits
  • Office based culture with occasional WFH that provides flexibility for eligible positions after training
  • Company-sponsored social events and intramural sports

 

Cincinnati Headquarters Experience

• • A modern corporate campus designed to support collaboration and productivity
  • Multiple on-site dining options in the heart of Madison Square
  • Free on-site parking
  • Convenient access to on-site 24-7 fitness and wellness facilities

 

What to Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.