Clinical Project Manager

Job Summary:

The Clinical Project Manager (CPM) designs; implements; and monitors clinical studies of new and modified in vitro diagnostic products. Ensures that the clinical studies are designed to validate the products’ intended use and meet regulatory requirements. Ensures clinical studies are conducted in compliance with Good Clinical Practice (GCP). Prepares clinical data reviews and participates in the preparation of regulatory submissions. Manages large projects; more complex projects; and/or several smaller related projects.

• Contributes to the implementation of clinical protocols and facilitates completion of final reports.
• Recruits clinical investigators and negotiates study design and costs.
• Responsible for directing human clinical trials, phases III & IV for company products under development.
• Participates in adverse event reporting and safety responsibilities monitoring.
• Coordinates and provides reporting information for reports submitted to the regulatory agencies.
• Monitors adherence to protocols and determines study completion.
• Coordinates and oversees investigator initiations and group studies.
• May participate in adverse event reporting and safety responsibilities monitoring.
• Responsible for implementing and maintaining the effectiveness of the quality system.　
• Supervise clinical research associates (CRA) and other employees in the completion of tasks and projects; train and mentor new employees, and serve as a resource for newly hired CRAs.
• Maintain a basic understanding of the principles of the assay and/or instrument. Remain current with regulatory requirements via professional and educational opportunities.
• Prepare and/or approve design validation plans; clinical protocols; clinical brochures; case report forms; sample consent forms; statistical plans; and other required documents for clinical studies.
• Identify and qualify clinical investigators and clinical sites; proposes and negotiate budgets for clinical studies; initiate and track payments to sites and manage expenses within the study budget.
• Manage or coordinate all aspects of the clinical monitoring process in compliance with GCP guidelines and regulations including review of all required essential documents necessary for study initiation and ensuring audit-ready study files throughout the duration of the study.
• Conduct site visits to provide training for investigator and staff; determine protocol and regulatory compliance and prepare required documentation ensuring data reported is accurate; complete and verifiable.
• Maintain and document professional communication with the clinical site, cross-functional project team, and management throughout the duration of the study.
• Conduct data reviews; prepare data summaries; create the clinical sections of regulatory submissions; strategize and/or coordinate responses to regulatory agencies’ questions regarding the clinical study.
• Travel: up to 25% (the USA only, e.g., other office locations, client hospitals, reference labs, etc.)
• Accountability:
  • Successful and timely completion of clinical studies directly impacts the ability to meet product market entry dates.
  • Early identification of unsatisfactory results; operations; or specific problems allows immediate action to be taken by appropriate groups.
  • Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project.
  • Accountable for project scope and scheduled completion date. Works under general management direction.
  • Participates in professional activities in the US and/or internationally.
  • Responsible for mentoring direct reports and their career development.

EDUCATION AND EXPERIENCE:

Required:

• Associates Degree
• The position requires minimum of 7 years of experience

Preferred:

• B.A. or B.S. in the biological sciences.
• A Master’s Degree is preferred. Other: Medical Technology MT(ASCP) or equivalent, or certification as a clinical research associate (CCRA) is desirable.
• This position requires an understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and the scientific, statistical, regulatory, and compliance requirements of clinical research.
• Minimum of 7 years of clinical research-related experience, of which at least 3 years of experience with clinical studies conducted per GCP with direct clinical site monitoring and/or clinical site management experience functioning in a lead capacity with mentoring, supervisory, or demonstrated leadership role.
• This position requires previous experience managing large or complex clinical studies; the ability to achieve goals through interaction with individuals not under their direct control; excellent oral and written communication skills, familiarity with desktop computer office software, and participation in professional activities outside of normal business hours.