Senior Clinical Project Manager

Arsenal Medical Inc. is a Boston metro based, privately held, clinical stage, medical device start-up company committed to transforming medicine through the novel application of in situ forming materials to meet today's challenging unmet clinical needs. Our in situ forming biomaterials platform creates customized mechanical implants in the body to control the flow of bodily fluids, fill complex anatomical spaces, and/or apply physical pressure. These implants are formed by delivering liquids with tunable chemistries to specific locations in the body using minimally invasive delivery systems. Once at the target anatomy, the liquids react to form solid implants that take the shape of complex cavities in the body. We create solutions that address some of today’s most challenging and critical unmet medical needs.

The Sr. Clinical Project Manager develops and executes clinical development plans and provides clinical research expertise. This person is hands-on and thrives in a fast-paced startup environment, is nimble to work on multiple activities simultaneously and is motivated by the opportunity to research new technologies.

Essential Functions

  • Lead the development, design, and execution of clinical trials for novel interventional Class III products
  • Manage CROs responsible for clinical monitoring, safety, and data management to ensure on-time execution of high-quality work
  • Create and manage study timelines and budgets ensuring that all reporting standards are met, and studies are executed according to plan; may manage multiple studies concurrently
  • Manage the selection process for vendors and CROs; serve as the lead sponsor contact with outside organizations such as study sites, CROs, central laboratories and other contract organizations; build strong relationships with trial investigators, study coordinators, and CROs
  • Manage teams in the writing of clinical documents for regulatory submissions
  • Serve on project core teams and provide clinical operations expertise
  • Oversee on-time supply of devices for the clinical study and maintains device accountability
  • Perform on-site qualification, initiation, interim and close-out monitoring visits, as necessary; escalate issues to Sr. Management as needed
  • Develop site recruitment plans and manage patient eligibility
  • Communicate and manage timeline, budget and study risks during study execution; prepare written reports to communicate clinical progress to external partners
  • Oversee data collection and integrity in support of safety reviews and study reports
  • Ensure overall data quality and integrity and human subject protection by managing studies according to regulatory requirements
  • Oversee company’s clinical compliance in preparation for potential BIMO audits
  • Write clinical SOPs, as needed

Requirements

  • Bachelor’s Degree is required, preferably in medical/scientific field
  • Minimum 5 years’ experience in clinical research environment; title will be commensurate with experience
  • Willing to travel up to 10-20%, including some international and weekend travel
  • Successful experience in managing FDA and Outside US regulated medical device clinical trials; prefer industry/sponsor experience
  • Experience engaging thought-leaders in clinical trial design and execution
  • Solution driven and flexible strategic thinker
  • Experience managing a functionally and geographically diverse team
  • Excellent verbal and written communication skills
  • Highly organized

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Arsenal Medical, Inc. is an Equal Opportunity Employer.