Clinical Trial Manager II

Posting Date 4 months ago(2/3/2022 2:54 PM)
Requisition ID
2022-10280
Job Location(s)
Pittsburgh PA United States
Travel
10-20%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Clinical

Overview

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) II at Cook MyoSite Inc. is responsible for the management of the Cook MyoSite clinical trials and clinical trial vendors/CRO, achieving clinical trial timelines and milestones, and being proactive with internal/external team communications. The Clinical Trial Manager II 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.

Responsibilities

• Responsible for the global management of assigned clinical trial(s) which may include but is not limited to, leading cross functional teams in study start-up activities, contract and budgeting, patient recruitment and enrollment, safety, medical monitoring, etc.
• Serves as the clinical trial point of contact and liaison between the CRO/vendors and Cook MyoSite.
• Responsible for tracking and achieving study timelines and milestones, providing appropriate vendor management and oversight, delivering regular internal/external team communications, and handling identification and escalation of issues.
• Represents 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.
• Responsible for implementation and oversight of assigned clinical trial(s) Trial Master File (TMF) for inspection readiness.
• Serves as a resource for the Product Management team (PM) by providing clinical trial metrics that aide in production forecasting, providing product feedback as needed, and keeping PM informed of product complaints.
• Helps to identify potential new clinical site relationships and maintain a database with contact information.
• Develops 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.
• Presents monthly updates and annual business plans to Clinical Affairs Manager and other stakeholders.
• Travels to national professional meetings as a representative of Cook MyoSite, as needed.
• Assists as requested in the preparation and follow up of internal process audits, vendor and/or clinical site quality audits as well as regulatory inspections.
• Assists with the planning of Investigator Meetings.
• Assists with the negotiation and management of clinical trial budgets and clinical trial documents.
• Assists with mentorship and training of CTMs and/or other Clinical Development roles, as requested.

Qualifications

• 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 is preferred
• Minimum of 1-year experience in vendor management is preferred

• 3 years of experience in clinical research environment is preferred
• 2 years of experience working for a CRO or as a Research Coordinator is preferred
• CCRP, CCRA, or CCRC certification is preferred

• Proficient knowledge of Microsoft Office software, and other general office equipment.

• Maintain frequent communication with the Clinical Affairs Manager and other support functions
• Strong written and verbal communication skills for interactions with clinical sites, vendors, and internal colleagues

• Must maintain company quality and safety standards

• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability

 

Physical Requirements:

• Setting: Remote / Field Based: General office or home office 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.

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