Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.
The Clinical Trial Manager (CTM) is responsible for the management of the Cook MyoSite clinical trials and clinical trial vendors/CRO, achieving clinical trial goals and timelines, and being proactive with internal/external team communications. The CTM is required to be an expert in their assigned disease state(s) and clinical landscape, and therefore providing input for the AMDC clinical development program.
• Responsible for global management of assigned clinical trial(s) by leading cross functional teams that may include tasks specific to study start-up, regulatory, contract and budgeting, safety, medical monitoring, etc.
• Serves as the clinical trial lead and the liaison with the CRO and Cook MyoSite, creation and tracking of timelines, vendor management and oversight, regular internal/external team communications, identification and escalation of issues, and coordination with internal departments.
• Represent Cook MyoSite as the expert on the AMDC product, clinical trial procedures, clinical landscape, disease state, anatomy, and processes with outside vendors and internal teams.
• Serve as a resource for the Product Management team (PM) by providing monthly clinical trial metrics that aide in production forecasting, providing product feedback as needed, and keeping PM informed of product complaints.
• Help to identify potential new clinical site relationships and maintain a database with contact information.
• Help to manage and maintain the eTMF for assigned clinical trial(s).
• Develop an understanding of the complex scientific concepts regarding the AMDC product and the proposed mechanism of action to comprehend highly detailed scientific data and scientific publications.
• Present monthly updates and annual business plans to Clinical Affairs Manager and other stakeholders.
• Undergraduate degree in Natural Science, Clinical Research, Regulatory Affairs or Business or 4 years direct, relevant experience in clinical research or clinical trial-related work and GCP environment
• Minimum of 3 years’ experience in project or program management preferred
• Minimum of 1 year experience in vendor management preferred
• 3 years of experience in clinical research environment
• 2 years of experience working for a CRO or as a Research Coordinator
• Proficient knowledge of Microsoft Office software, and other general office equipment.
• CCRP, CCRA, or CCRC certifications preferred
• Clinical Setting
• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.
• Must be (a) physically capable of operating a motor vehicle on a regular basis, (b) a holder of a valid driver's license, and (c) in good standing to legally operate a motor vehicle.
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.
• Must be able to lift/push/pull up to 25 pounds on an occasional basis with or without reasonable accommodations.
• Ability to reside in any U.S. metro area and work remotely.
• General office, warehouse and laboratory setting when working at Cook MyoSite headquarters.
• Up to 20% international and domestic travel.