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 Senior Clinical Trial Manager (CTM) at Cook MyoSite, Inc. is responsible for independent management of assigned Cook MyoSite clinical trials and clinical trial vendors/CRO, achieving clinical trial timelines and milestones, and being proactive with internal/external team communications. The Senior CTM is required to be an expert in clinical trial operations, their assigned disease state(s) and clinical landscape, and therefore providing advisory operational input for the AMDC clinical development program.

Responsibilities

• Independently manages assigned global clinical trial(s) which may include but is not limited to, leading cross functional teams in study start-up activities, reviewing/approving study documents (i.e., clinical trial agreements, clinical site budgets, site selection and initiation reports, etc.), safety management, medical monitoring, et. al. • Ensures clinical trial activities and deliverables are completed on time, within budget, and are compliant in accordance with FDA/applicable regional regulations, GCP/ICH requirements, and Cook MyoSite SOPs.• Clinical trial(s) point of contact between Cook MyoSite and the CRO (specifically, the CRO operational leads) and external/third-party vendors (i.e., electronic endpoint data collection, supply distribution, patient recruitment and marketing agencies, etc.); assures clear and direct communication between groups.• Responsible for performance of CROs and third-party vendors to ensure compliance with study protocol and in accordance with the scope of work; quickly identifies areas of concern and escalates accordingly.• Leads the identification, qualification and evaluation, selection, and oversight of clinical sites activities. • Leads the negotiation and management of clinical trial budgets and clinical trial documents.• Responsible for tracking and achieving clinical trial(s) timelines and milestones, delivering regular company communications, and handling escalation of issues. • Responsible for patient recruitment strategy and enrollment direction.• Interfaces as the Subject Matter Expert (SME) and serves as a coach or mentor for the CRO or external/third-party vendors performing functional tasks related to Cook MyoSite clinical trial(s) or the AMDC product.• Initiates, leads, and implements continual process improvements during clinical trial(s) alongside the CRO; strong emphasis on quality, compliance, and consistency within the entire clinical development program.• Performs initial review of invoices and tracks within the study budget according to the forecast working closely with the Manager, Clinical Affairs and the Director, Clinical Development. • Participates in CRO/external/third-party vendor Request for Proposal (RFP) and selection process for outsourced activities. • Responsible for oversight of assigned clinical trial(s) Trial Master File (TMF) for inspection readiness; performing routine audits.• 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.• Identifies potential new clinical relationships and maintains a database with contact information.• Serves in a mentorship role and trainer of CTMs and/or other Clinical Development roles, as requested.• Actively participates in the preparation and follow up of internal process audits, vendor and/or clinical site quality audits as well as regulatory inspections.• Leads the planning of Investigator Meetings.• Strong 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 the Manager, Clinical Affairs and other stakeholders, as requested.• Travels to international and national professional meetings as a representative of Cook MyoSite, as needed.

Qualifications

• Undergraduate degree in Natural Science, Clinical Research, Regulatory Affairs or Business or 8 years direct, extensive experience in industry-sponsored clinical research operations or clinical trial-related work and GCP environment

• Minimum of 5 years of experience in project or program management• Minimum of 5 years of experience in vendor management

• 8 years of experience in clinical research environment• 5 years of experience working for a CRO or a Sponsor• CCRP, CCRA, or CCRC certifications highly preferred

• Proficient knowledge of all Microsoft Office software and other general office equipment.• Experience using clinical trial software systems/devices, such as electronic data capture (EDC) systems, clinical trial management systems, electronic trial master file (eTMF) systems, interactive web response systems (IWRS), and electronic clinical outcome assessments (eCOA).

• Maintain frequent communication with the Manager, Clinical Affairs and other support functions

• Must maintain a high level of professionalism, business acumen, and excellent customer service skills• Demonstrates critical thinking and ability to execute goals set by the organization and department manager

Physical Requirements:

• Remote/Field Based Setting: Full time Remote position | General office or home office setting

• Travel (Domestic & International): 10-20%

• 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