Clinical Trial Manager

A P&G Clinical Trial Manager will be responsible for:

• Procedural work and expertise in Application work by combining hands-on experimentation with scientific principles and knowledge from science/engineering education to drive foundational technical understanding and solve technical problems.
• Delivers technical outputs which address critical innovation challenges and completion of key milestones.
• The Clinical Trial Manager (CTM) is a key member of the clinical team with responsibility for defining and managing the quality execution of clinical studies.
• Partner closely with product and technology development to design and execute clinical studies for claims support, credentialing, decision making, and fundamental understanding.
• The CTM role is pivotal for driving robust human testing and clinical trials that are compliant with established governance principles, including ICH-GCP Guidelines.
• Responsibilities: Design, implementation, and management of clinical trials,
• Development of both external and internal networks for the integration of key components of a successful clinical trial.
• Management of study logistics, timelines, and budget/expense tracking. Prepare documentation for study placement and clearances, clinical trial protocols, and IRB submissions, as needed.
• Conduct study close out and tasks, including documentation and archiving of study materials.
• Contribute to the development of Standard Operating Procedures and adhere to all aspects of Governance and Quality systems.
• Represent clinical operations are regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed.

Must Haves:

• B.S or B.A. degree (minimum)
• 2 years of CTM experience (minimum)
• ICH-GCP training and certificate
• Experience with Study management, study deliverables (including timelines), monitoring study and maintain study binder
• Experience with collaboration with clinical scientists to execute the study protocol
• FDA regulatory expertise for clinical study
• Direct experience with P&G clinical test in the past

Nice to have:

• MS degree (PHD)
• 5 years of CTM experience
• CCRA certification
• Study protocol development, content form development, study budget management
• Cincinnati based
• Develop study protocol 

P&G’s freelancer opportunities are for project-based or other short-term engagements that require specialized skills. Successful candidates for freelancer opportunities will not be considered employees of The Procter & Gamble Company or any of its subsidiaries nor will candidates be eligible for employment benefits. Candidates looking for regular full-time employment opportunities should begin their search here: pgcareers.com.