Contract - Clinical Research Project Manager

Clinical project manager role responsible for daily management of clinical research studies to support the company’s regulatory and legislative product approvals.  The position entails the clinical operation activities and the management of clinical studies in compliance with appropriate regulations and procedures.

• Ensure that clinical trials are conducted in accordance with applicable regulations, IRB requirements, and company policies including maintaining a state of audit readiness.
• Liaison between StimLabs, investigational sites, and CROs to coordinate and document clinical research studies including study start-up, attending team meetings, and managing the project timeline.
• Oversee project budgets, assessing invoice accuracy, budget change forms, accruals, monthly budget reports, and Sunshine Act reporting.
• Ensure the collection and management of essential documents for clinical studies.
• Generate protocol deviation forms as well as any associated assessments for CAPAs.
• Monitor the collection and analysis of clinical data.  Interface with applicable clinical research databases as necessary for research studies.
• Collaborate on clinical study reports based on expected timelines.
• Collaborate on monthly Newsletters for clinical Sites.
• Conduct basic statistical analyses for technical support of product line as needed.
• Conduct literature reviews and write research summaries related to product line.
• Evaluate and report on AEs, complaints, and failures associated with the product line.
• Assist with the execution of peer-reviewed projects (publications, posters, abstracts) and marketing literature.
• Review and train on appropriate StimLabs SOPs for clinical research.
• Other assigned responsibilities as deemed necessary to meet project deadlines.

• Bachelor's or advanced degree in a relevant field required (i.e., Life Sciences, Pharmacy, Engineering, or a related discipline).

• Minimum 5 years of experience executing clinical research studies and/or relevant medical product development and testing experience.
• Demonstrate project management, critical thinking, and communication skills.
• Proficient knowledge of medical terminology.
• Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software - SmartSheets), project management techniques and tools; and web-based applications.