Clinical Studies Project Manager
About the Opportunity
The Clinical Studies Project Manager is responsible for the successful execution of our clinical studies to include initiation, monitoring and completion of clinical study deliverables and proactive identification and resolution of clinical project issues. The Clinical Studies Project Manager is also responsible for the quality and timely transfer of study data to the data analysis team.
Reports to Chief Scientific Officer
Manages the following roles:
Clinical Research Associates (fulltime or contractual)
Is a full time position ideally based in our corporate office, located in Bethesda, Maryland
Requires travel, as needed across the assigned market.
Maintains a customer focus, a commitment to excellence, and adherence to compliance policy and medical device regulation in all work decisions to uphold BrainScope’s “Culture of Quality.”
We offer a competitive salary, strong benefits and stock options to complete the package.
Work creatively with research sites to facilitate and supervise the conduct of clinical trials, build/maintain an effective working relationship with sites to gather constructive feedback and communicate ideas and results.
Participate in the identification of potential investigators and clinical sites and aid in obtaining contracts and Investigational Review Board (IRB) approval along with supporting documentation required for study start-up.
Along with Clinical Research Associate (CRA), manage clinical site initiation, and provide onsite BrainScope medical device training for study staff, advise and train site personnel on protocol and regulatory requirements for study conduct
Manage site monitoring visits and follow-ups including review and audit of on-site files and records, clinical report forms, and source documents for completeness, accuracy, consistency, and compliance
Develop, maintain, and execute Data Monitoring Plans and interim reporting (study enrollment metrics, complaint handling report, etc.) for all studies and trials
Ensure all clinical aspects of studies are being carried out in accordance with Good Clinical Practice (GCP), regulatory agency guidelines, company SOPS, and overall protocol clinical objectives for all phases of clinical trials
Work in conjunction with Data Manager to support data handling and management processes ensuring data integrity is maintained by performing regular quality checks and supporting ongoing query management and resolution
Work with other company disciplines (e.g., Engineering, Algorithm, and Regulatory/Quality Assurance) to support product development and study objectives
Provide oversight and direction to CRA(s)
Bachelor’s degree (minimum)
Minimum of 5 years monitoring experience with CRO or sponsor company preferred; minimum of 7 years of total experience in a clinical research setting a plus;
Medical device related study monitoring experience strongly preferred
Outstanding organizational skills, attention to detail, planning and prioritizing, efficient time management, concern for quality, common sense and flexibility
Strong computer skills: ability to learn new technology and systems
Operate effectively in a multi-disciplinary, team-oriented culture that emphasizes professional development
Travel as required; must be able to work weekends when necessary to meet the needs of our clinical sites
Demonstrated exceptional written and oral communication skills (e.g., final study reports)
Comfortable working in a fast-paced start up environment
Qualified applicants are encouraged to send their resume and a cover letter including availability to firstname.lastname@example.org.
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