The Clinical Project Manager will be responsible for all aspects of planning, coordination, and execution of clinical projects mainly in support of indication expansion projects at Laborie in accordance with the relevant standards as well as Laborie standard operating procedures. This person will collaborate with cross-functional partners to support development and execution of the regulatory strategy, oversee design and development of the required study protocols and informed consents, oversee data collection methods (i.e., case report form design and development; database build), site selection, initiation and training, and all other clinical trial activities as assigned. The Clinical Project Manager will also interface with KOLs to gather real-world data.
Roles And Responsibilities
- Establishes, implements, and manages clinical projects including the following activities: project planning and clinical study design development; collaborating with cross functional groups with varied functional expertise; establishing and monitoring clinical timelines and budgets, anticipating schedule impacts and adjusting project team activities as required.
- Develops core clinical documents, including the clinical study protocol, case report forms, informed consent forms, clinical study agreements, investigator manuals, investigator files, and all other necessary documentation for study initiation.
- Identifies, evaluates and audits investigational sites to determine site qualification for participation in clinical trials. Provides training to clinical investigators and study personnel regarding protocol requirements, data collection and reporting requirements as necessary.
- Supports clinical investigators with preparation and submission of required documentation to Institutional Review Boards (IRBs) for approval. Is aware of IRB reporting requirements, ensures maintenance of IRB approval throughout the duration of the study, and ensures compliance with national and international regulations.
- Ensures clinical studies are conducted in compliance with the respective investigational plan and all applicable regulations, IRB requirements, and Company policies and procedures.
- Supports research programs process by reviewing clinical research proposals in accordance with Company policies/procedures and may provide additional clinical expertise and/or administrative support, as necessary.
- Manage clinical publications strategy; Serve as subject matter expert (SME); lead and/or participate on cross-functional teams.
- Actively participate in the planning and supporting of clinical relationships with Key Opinion Leaders (KOLs) and speakers.
- All activities must be performed in compliance with the Quality System.
- Performs duties in compliance with environmental, health and safety related site rules, policies, or governmental regulations.
- All other duties as assigned.
- Master's degree or equivalent experience required.
- Medical Device IDE experience required.
- Ability to travel: 10-20%.
- Requires 8+ years of relevant work experience to develop the competence to demonstrate and fulfill the duties and responsibilities of the position.
- Experience with regulations and standards affecting the medical diagnostic industry.
- Experience with or exposure to Good Clinical Practices.
- Ability to convey communications clearly, concisely, and accurately.
- Ability to form and develop interpersonal, professional relationships and exhibit socially and professionally appropriate behavior.
- Ability to work independently and in groups.
- Demonstrated initiative and problem-solving skills.