Senior Clinical Trials PM Lead - Hybrid

Olympus America, Inc.; Westborough (MA); Híbrido; USD 138.000 - 193.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

401(k) matching

Parental leave

Descripción de la vacante

Olympus America, Inc. is seeking a Senior Clinical Project Manager to lead operational execution of large-scale clinical trials, manage timelines and budgets, and coordinate cross-functional teams across Clinical Strategy, Data Management, and Monitoring.

The role emphasizes vendor management, regulatory compliance (GCP, FDA), and mentorship of CPM staff; hybrid work location in Massachusetts (Westborough) and Center Valley, PA.

Formación

• Bachelor’s degree in health sciences or related field and a minimum of 12 years of clinical trial management experience or an equivalent combination of education and work experience.
• Experience managing scope, budget and timeline.
• Minimum of 3 years of experience managing teams, direct reports, or leading complex programs and the ability to coach, develop, and influence.
• Has consistently delivered projects with broad business impact across multiple teams.
• Has experience tackling challenging business problems that impact multiple teams.

Responsabilidades

• Lead operational execution of complex clinical trials from study start-up through closeout, ensuring delivery against study timelines, budgets, and operational milestones.
• Serve as the central hub for the study core team, coordinating activities across Clinical Strategy, Data Management, Biometrics, Monitoring, Site Management, Data Systems, and Clinical Trial Associates.
• Ensure cross-functional alignment and accountability for study deliverables, tracking progress across functional areas and escalating risks, delays, or resource constraints to functional leadership when needed.
• Oversee end-to-end clinical trial operations, including site start-up, contract and site budget review processes, enrollment progress, monitoring strategy, vendor performance, and study closeout.
• Manage study timelines, budgets, and operational metrics, including budget forecasting and tracking of study financial performance.
• Coordinate the development of key study documents and operational plans, including protocols, CRFs, informed consent form (ICF), monitoring plan, data management plan, training plan, safety plan, etc.

Conocimientos

Budget management

Team leadership

GCP knowledge

FDA regulations

Cross-functional collaboration

Educación

Bachelor’s degree in health sciences or related field

Descripción del empleo

Olympus America, Inc. is seeking a Senior Clinical Project Manager to lead operational execution of large-scale clinical trials, manage timelines and budgets, and coordinate cross-functional teams across Clinical Strategy, Data Management, and Monitoring.

The role emphasizes vendor management, regulatory compliance (GCP, FDA), and mentorship of CPM staff; hybrid work location in Massachusetts (Westborough) and Center Valley, PA.