Clinical Trial Lead – Hybrid Ops & Site Leadership

Hologic, Inc.; San Diego (CA); Híbrido; USD 117.000 - 182.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

Descripción de la vacante

Hologic, Inc. is seeking an experienced Clinical Trial Lead to drive the execution of clinical studies in a hybrid setup across Marlborough, MA or San Diego, CA.

This role requires in-office presence at least three days per week and oversight of CRA/CTA teams, monitoring plans, site selection, budgeting, and regulatory documents. You will ensure compliance with GCP and drive study metrics, training, and continuous process improvements, contributing to leading diagnostics programs in women’s

Formación

• Experience in clinical research in an industrial setting.
• Experience in IVD environment preferred.
• Experience in study management for moderate to complex studies.

Responsabilidades

• Plan and execute clinical operations for simple to complex trials.
• Manage CRAs and CTAs to ensure compliance with GCP and procedures.
• Develop monitoring plans and study tools including ICFs.
• Train CRA team and maintain documentation of training.
• Mentor CRAs and provide on-site support as needed.
• Monitor site budgets and contract negotiations; report expenses monthly.
• Drive trial conduct and identify trends in CRA/site activities.
• Create metrics to track timelines and study goals.
• Support investigator meetings and TMF quality control.

Conocimientos

Advanced knowledge of clinical trialPr

Advanced knowledge of clinical ops

Advanced knowledge of clinical trialDB

Technical computer systems

Lead and influence without authority

Educación

Bachelor’s degree in Life Sciences or equivalent qualification

Descripción del empleo

Hologic, Inc. is seeking an experienced Clinical Trial Lead to drive the execution of clinical studies in a hybrid setup across Marlborough, MA or San Diego, CA.

This role requires in-office presence at least three days per week and oversight of CRA/CTA teams, monitoring plans, site selection, budgeting, and regulatory documents. You will ensure compliance with GCP and drive study metrics, training, and continuous process improvements, contributing to leading diagnostics programs in women’s