Clinical Program Manager
il y a 11 heures
**Description**
The Clinical Research Program Manager is responsible for leading all aspects of clinical trial management across the study life-cycle from planning to execution to closure. They work with cross functional partners or Contract Research Organizations to collect and deliver high quality evidence, enabling patient access to advanced care of their vascular disease.
**Responsibilities**
*
Designs, plans, and implements the clinical trial to demonstrate safety, efficacy, economic, and quality of life outcomes for the performance of Inari products and solutions potentially at a global scale.
- Determines study objective, strategy, scope and schedule in order to meet business needs.
- Able to effectively influence cross-functional team members and external medical professionals to ensure project deliverables are completed on time/budget.
- Partners and aligns with internal and external stakeholders to support global regulatory approvals, reimbursement coverage, market penetration, and market expansion.
- Able to see multiple viewpoints and build consensus to reach resolutions.
- Help establish the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of medical devices.
- Develops the Clinical Investigational Plan and supporting documents (IB, PIC,Safety Plan, Data Management Plan, etc) in consultation with the cross-functional project teams, investigators and the clinical team
- Provide clinical training of investigators, center staff, CRO partners, and Inari team members.
- Participates with technical and clinical experts in safety review of clinical data.
- Evaluate, analyze and validate all clinical data per data management plan for ongoing analysis and publications throughout study execution.
- Provides robust sponsor oversight to all clinical sites and CRO in compliance with CIP and overall clinical objectives.
- Participate in the selection and management of CRO partners.
- Perform site visits to supervise and coordinate clinical studies and to discuss /coordinate publication initiatives.
- Evaluates clinical data/information, providing interim and final reports, convening and directing investigator conferences to review findings and advise on direction.
- Develops a high level of professional scientific technical and clinical expertise through familiarity with relevant literature, by attending scientific meetings, and by interacting with various inside/outside experts or departments/institutes.
- Develops and manages budgets for assigned clinical studies and / or clinical research projects.
- Engages key physician investigators in the development and/or execution of clinical research.
- Prepares outlines, summaries, status reports, etc. for distribution and communication with other departments and executive leadership.
- Follows and helps iterate Clinical SOPs, systems and processes ensuring quality study management.
**Qualifications**
- Bachelor’s degree in the life sciences.
- Master’s degree with a demonstrated research background is preferred.
- Experience with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
- Solid understanding of industry trends for clinical and regulatory pathways.
- Proficient project management skills.
- Minimum of 8-10 years’ relevant clinical research experience with significant project management experience.
- Healthy disdain for the status quo.
- Ability to thrive in a fast-paced and dynamic early stage company work environment.
- Medical device trials experience preferred.
- Detail oriented with ability to deliver high quality output consistently and on time.
- Ability to thrive in times of change while adhering to cultural focus on People and Patients.
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