Clinical Program Manager (Remote)
About The Position
As a Clinical Program Manager, you will lead all aspects of clinical trial management across the study life cycle—from planning to execution to closure. You will collaborate with cross-functional teams and CRO partners to deliver high-quality evidence supporting regulatory approvals, reimbursement, and market expansion. Design, plan, and implement clinical trials to demonstrate safety, efficacy, and quality outcomes for Inari products globally. Define study objectives, strategy, scope, and timelines to meet business needs. Partner with internal and external stakeholders to support regulatory approvals and market access. Develop Clinical Investigational Plans and supporting documents (IB, PIC, Safety Plan, Data Management Plan). Provide clinical training for investigators, site staff, CRO partners, and internal teams. Oversee safety reviews and validate clinical data for analysis and publications. Manage CRO selection, oversight, and site visits to ensure compliance with CIP and objectives. Prepare interim and final reports, lead investigator meetings, and coordinate publication initiatives. Develop and manage budgets for assigned clinical studies. Follow and improve Clinical SOPs, systems, and processes for quality study management.
Requirements
- Bachelor’s degree in science or health care related field.
- 8 years of relevant clinical research experience with minimum 4 years of clinical study management experience.
- Experience with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
- Strong project management skills and ability to influence cross-functional teams.
- Excellent communication, organizational, and analytical skills.
Nice To Haves
- Master’s degree with a demonstrated research background.
- Clinical research or project management certification (eg, CCRP, ACRP, PMP).
- Experience in medical device clinical trials.
- Familiarity with global regulatory and reimbursement pathways.
- Experience leading cross functional teams
Responsibilities
- Lead all aspects of clinical trial management across the study life cycle—from planning to execution to closure.
- Collaborate with cross-functional teams and CRO partners to deliver high-quality evidence supporting regulatory approvals, reimbursement, and market expansion.
- Design, plan, and implement clinical trials to demonstrate safety, efficacy, and quality outcomes for Inari products globally.
- Define study objectives, strategy, scope, and timelines to meet business needs.
- Partner with internal and external stakeholders to support regulatory approvals and market access.
- Develop Clinical Investigational Plans and supporting documents (IB, PIC, Safety Plan, Data Management Plan).
- Provide clinical training for investigators, site staff, CRO partners, and internal teams.
- Oversee safety reviews and validate clinical data for analysis and publications.
- Manage CRO selection, oversight, and site visits to ensure compliance with CIP and objectives.
- Prepare interim and final reports, lead investigator meetings, and coordinate publication initiatives.
- Develop and manage budgets for assigned clinical studies.
- Follow and improve Clinical SOPs, systems, and processes for quality study management.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
