Clinical Project Manager

Arsenal Medical Inc. is transforming medicine through materials science by generating a pipeline of innovative products that improve therapy by treating at the site of injury and disease. We create solutions that address some of today’s most challenging and critical unmet medical needs. Arsenal Medical has built a state-of-the art research and development environment in the Boston metropolitan area.

We are looking for a hands-on Clinical Project Manager / Senior Clinical Project Manager to work with us to develop and execute clinical development plans and provide operational clinical research expertise. This person will thrive in a fast-paced startup environment, be nimble to work on multiple activities simultaneously, work well in team and group environments and be motivated by the opportunity to research new technologies.

Key areas of responsibility

  • Lead the development, design, and execution of clinical trials of novel medical device products
  • Establish and monitor clinical study budgets
  • Facilitate the development of study templates such as but not limited to investigational study budget, informed consent form, and source documents
  • 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 and CROs
  • Manage CROs responsible for clinical monitoring, safety, and data management to ensure on-time execution of high-quality work
  • Ensure compliance of clinical trials to GCP, state and local laws and standard compliance standards
  • Manage EDC development and User Acceptance testing for study implementation
  • Oversee data collection and integrity in support of safety reviews and study reports
  • Oversee or support clinical trial monitoring
  • Manage processes that ensure on-time supply of devices for the clinical study and maintain device accountability
  • Perform on-site qualification, initiation, interim and close-out monitoring visits, as necessary
  • Develop site recruitment plans and manage patient eligibility
  • Manage teams in the writing of clinical documents for regulatory submissions
  • 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 and develop clinical SOPs as needed
  • Serve on project core teams and provide clinical operations expertise
  • Create and manage study timelines ensuring that all reporting standards are met and studies are executed properly
  • Communicate and manage risks around timelines during study execution; prepare written reports to communicate clinical progress to external partners
  • Manage escalation of study-related issues and communicate as appropriate with management
  • Present ongoing study updates to senior leadership

Requirements

  • Bachelor’s Degree is required, preferably in medical/scientific field
  • Minimum 7 years’ experience in clinical research environment; title will be commensurate with experience
  • Willing to travel up to 25%
  • Experience in running FDA and outside US regulated medical device clinical trials
  • 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
  • Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight
  • Ability to manage and work collaboratively with team members on aggressive timelines to meet project milestones and deliverables

Please send resumes to [email protected]

Arsenal Medical, Inc. is an Equal Opportunity Employer.