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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) 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 (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 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.
• 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• Minimum of 1-year experience in vendor management
• 3 years of experience in clinical research environment• 2 years of experience working for a CRO or as a Research Coordinator• CCRP, CCRA, or CCRC certifications preferred
• Proficient knowledge of Microsoft Office software, and other general office equipment.
• 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• 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
• This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.• 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:
• 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.
Full Time
Wholesale
$81k-107k (estimate)
03/07/2023
04/16/2023
cooksf.com
OAKLAND, CA
25 - 50
2006
Private
NONA LIM
$10M - $50M
Wholesale
Cook! makes gluten-free eating tasty, easy, and healthy and also offer gluten-free meals delivery and dairy-free entrees.
The job skills required for Clinical Trial Manager include Clinical Trial, Clinical Research, Microsoft Office, Planning, Critical Thinking, Verbal Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Trial Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Trial Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Trial Manager positions, which can be used as a reference in future career path planning. As a Clinical Trial Manager, it can be promoted into senior positions as a Clinical Research Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Trial Manager. You can explore the career advancement for a Clinical Trial Manager below and select your interested title to get hiring information.
If you are interested in becoming a Clinical Trial Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Clinical Trial Manager for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Clinical Trial Manager jobs
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Step 3: View the best colleges and universities for Clinical Trial Manager.