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Job #03007

About our client Our client is a medical device company based in Burlington, Massachusetts. They focus on the development of devices that differentiate between healthy and diseased tissue. They have a product on the market that is being used to diagnose and treat patients with diabetic foot ulcers. Our client is currently expanding its research and has initiated several new studies. This is a great opportunity for the right person to join a leadership team focused on building a market for the next generation of medical devices! Position Location Clinical Operations Manager Burlington, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage all aspects of company’s investigational studies including clinical trial planning, execution and closeout 2) Oversee the development and implementation of clinical research processes and systems 3) Develop and implement the clinical operations strategy 4) Manage CROs under the assigned scope of work 5) Negotiate and establish contracts with external research sites 6) Manage clinical protocols, CRFs, study reports as well as the informed consent process and documentation 7) Develop training programs for internal and external resources 8) Support the development and execution of company’s clinical studies to ensure high quality and timeliness of clinical results Requirements 1) BS/RN in a related field 2) 3 – 5 years of experience including a combination of monitoring and in-house clinical operations work 3) Clinical research experience 4) Previous project management experience in leading clinical trials including multi-site clinical trial management 5) In-depth knowledge of ICH/GCP, 21 CRF and other regulatory processes 6) Excellent communication, interpersonal and teamwork skills 7) Proficiency in computers (MS Word, Excel and PowerPoint) 8) Detail-oriented with good organizational and time-management skills 9) Ability to plan, coordinate and execute with minimal supervision 10) Ability to manage multiple projects with competing priorities 11) Ability to delegate tasks while maintaining responsibility for the final result 12) Willingness and ability to travel (up to 35%)