Reports to: SVP Clinical Operations & Biometrics Location: NY or NC
The Clinical Project Manager is responsible for the routine cross-functional operations of assigned studies. The Clinical Project Manager acts as the team leader, ensuring that assigned studies are delivered successfully, on-time, within budget, according to the expectations and with the highest level of quality possible.
- Responsible for the overall coordination and management of clinical trials from start-up through close-out activities.
- Serve as the primary liaison with the project team for assigned studies.
- Oversee activities with respect to regulatory document collection and Trial Master File maintenance for applicable studies and directly assist with such activities as needed.
- Negotiate site contracts and/or budgets and oversee accurate and timely distribution of investigator grants.
- Develop and maintain project metrics, timelines, budget and deliverables including project plans, trackers and tools for assigned projects.
- Develop, implement and communicate project plans, monitoring plans, regulatory plans and all other applicable study materials.
- Facilitate team training in accordance with the protocol and/or project requirements, including therapeutic, protocol specific and process training.
- Direct all project staff across functional areas to facilitate study progress.
- Assist with initial investigator recruitment and evaluation by reviewing site feasibility questionnaires and investigator CVs.
- Develop study specific Standard Operating Procedures (SOPs) and other study-specific management tools as needed.
- Coordinate, plan and execute Investigator Meetings as needed.
- Oversee the supply of Investigational Product and other study materials to sites.
- Evaluate site activation and site enrollment against projections throughout the course of the study, escalating issues as required.
- Determine and implement patient retention strategies as needed.
- Assist with resolution of site and facility issues such as outstanding queries, overdue documentation, lab and study drug issues.
- Manage overall study budget, provide accurate budget forecasts, review pass-through costs and ensure project invoices and site/vendor payments are accurate, timely and in alignment with applicable agreements and Statement of Work (SOW).
- Lead internal project team meetings
- Communicate the progress of the study, potential risks and appropriate recommendations for identified risks to appropriate client and internal team members on a regular basis.
- Attend project team meetings.
- Oversee the creation and distribution of study-specific newsletters as required.
- Ensure monitoring reports are received, reviewed and signed off per specified timelines as defined in the Monitoring Plan and/or applicable SOPs.
- Ensure project documentation is complete, current, stored appropriately and audit-ready.
- Develop and maintain a close working relationship with study management team.
- Establish a strong working relationship with and act as a resource for investigative sites; troubleshoot site and patient concerns and critical project matters.
- Escalate issues and critical project matters in a timely manner to appropriate team members and senior management.
- Support study audits and respond to audit reports.
- Provide performance feedback on project team members to management.
- Collate and communicate end-of-study site performance metrics, issues and lessons learned to appropriate parties.
Qualifications / Requirements / Experience
- Bachelors degree or RN in related field
- PMP Certification a plus
- 5+ years of experience in clinical trials in medical device or life sciences technology-driven company.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- At least 3 years of Clinical Project Management experience in CRO setting
- Ability to travel as needed (investigator meetings & sites meetings)
- Experience in managing a group of CRA’s
- Work outside the normal office hours as required.
- Experience in establishing relationship with key opinion leaders, investigators and study personnel, especially in the respiratory field
- Exceptional negotiating skills along with financial acumen
- Strong knowledge of the device and drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials.
- Excellent written, oral communication and presentation skills
- Excellent interpersonal and organizational skills with demonstrated attention to detail.
- Ability to read, write and speak fluent English.
- Ability to build positive, productive client and team member relationships.
- Demonstrated management and problem-solving capabilities, strong critical thinking, and analytical skills
- Good computer skills with good working knowledge of a range of computer applications included but not limited to MS Work and Excel
- Ability to meet deadlines, multitasks, and prioritize based on project needs
- Ability to make sound decisions based on available information
- Ability to work both as part of a team and independently
- Ability to lead team meetings and teleconferences and provide accurate and comprehensive minutes
Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Clinical Project Manager - NY or NC: