Description
The Clinical Project Manager manages projects and people in conducting clinical trials of medical devices to ensure: the safety of subjects, the quality and integrity of data, and the proper management of study procedures according to ICH and GCP regulatory guidelines and Standard Operating Procedures.This position will focus on new therapies. This person will work closely with colleagues in Regulatory Affairs, Medical Affairs, Legal, Marketing and R&D to develop and execute clinical trial(s) for existing and/or new products within Vascular Therapies.Principal Accountabilities
- Responsible and accountable for one or more clinical trial(s) in new therapy areas.
- Project manage and coordinate all aspects of domestic and international clinical trial(s) from study start-up through close-out. This includes responsibilities across operations, study development, and project management.
- Manage clinical project(s) within approved budgets & timelines, and manage protocols andresource requirements across assigned trials.
- Collaborate with independent clinical advisors during the development of clinical protocols (regulated and non-regulated).
- Serves as a key member on project core team and may be asked to participate on cross functional PDP team as needed for assigned product.
- Works with nationally noted physicians and a Physician Steering committee.
- Ensure that trials are developed in a professional manner to permit publication at professional conferences or in medical journals.
- Recruit, negotiate compensation, manage deliverables and provide feedback to study consultants [contract research organizations (CROs), biostatisticians, independent core laboratories, clinical/medical experts, data managers, and medical writer].
- Oversee site and investigator selection process.
- Interact externally with clinical investigators, investigational sites, CROs, etc.
- Develop and/or review clinical project deliverables, such as protocols/amendments, Case Report Forms (CRFs), investigator brochures, informed consent, trial manuals, operational plans and other trial related documents.
- Manage forecasting of trial devices, if required, and oversee the accountability/reconciliation of such devices.
- Manage tracking of trial supplies and usage, enrollment of subjects, regulatory document flow, study timelines, performance metrics, data flow, etc.
- Provide oversight of clinical trials(s) to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
- Support the coordination and attends investigator/study coordinator meetings.
- Provide oversight of clinical trial(s) to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
- Responsible for the identification of project risks and the development and implementation of the mitigations for these risks.
- Responsible for corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits.
- Responsible for ensuring the study is "audit ready" at all times (project team training records, central files, system validation, etc.).
- Provide regular updates regarding the status and progress of the trials to clinical management.
Qualifications
- Bachelor's level degree in life sciences, pharmacy, nursing or RN; Master's coursework preferred.
- 6 years minimum global clinical research experience in medical devices.
- 5 years project management in clinical trials - preferably with medical device.
- Demonstrate thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs/DOPs and policies.
- Experience in the management of device trials leading to a 510(k) and/or PMA is required.
- Excellent verbal and written communication skills (correspondence, reports, protocols, etc.).
- Strong knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Knowledge of clinical trial design and statistics.
- Strong communication, interpersonal, and problem solving skills.
- Excellent organizational and time management skills.
- Proven ability to work independently in a fast-paced environment.
- Ability to work in a highly matrixed team environment.
- Knowledge of and skill in using Microsoft Office suite, specifically, Word, Excel, PowerPoint, and Outlook.
- Ability to provide clear direction and guidance to others.
- Position requires approximately 10% travel (up to 20% during peak times).