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 biomaterials to meet today's challenging unmet clinical needs. The Clinical Project Manager 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 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
• Manage study timelines and budgets ensuring that all reporting standards are met, and studies are executed according to plan.
• Serve as the 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
• Serve on project core teams and provide clinical operations expertise
• Maintain device accountability
• Perform on-site or remote qualification, initiation, interim and close-out monitoring visits, as necessary; escalate issues to Sr. Management as needed
• Communicate and manage timeline, budget and study risks during study execution
• 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
• Contribute to writing of clinical SOPs, as needed

Requirements

• Bachelor's Degree is required, preferably in medical/scientific field
• Minimum 5 years' experience in clinical research environment
• Able to travel up to 30%, including some international and weekend travel
• Successful experience in managing FDA and Outside US regulated medical device clinical trials; prefer industry/sponsor experience
• Experience managing a functionally and geographically diverse team
• Excellent verbal and written communication skills
• Highly organized
• Able to work onsite 40%

Arsenal Medical, Inc. is committed to creating a diverse environment and is proud to be an equal opportunity employer. We will consider all qualified applicants for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected class