Remote Regulatory Project Manager - Clinical Trials

The Pennsylvania State University; Pennsylvania; A distancia; USD 81.000 - 122.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

75% tuition discount

Excellent benefits

Descripción de la vacante

The Beat Childhood Cancer Research Consortium (BCC) at the Penn State College of Medicine invites a remote, full-time Clinical Trial Regulatory Project Manager to oversee regulatory operations for 55+ hospital sites across the US, with a focus on compliance, documentation, and inspections.

Ideal candidates bring strong cIRB/IRB, FDA IND experience, and ability to coordinate multiple principal investigators and trials in a fast-paced environment. Remote with travel as needed.

Formación

• Master's degree required with related field.
• 6+ years of relevant experience or equivalent.
• Experience with regulatory compliance in clinical trials.
• Familiarity with cIRB/IRB, FDA IND requirements.
• Ability to train and guide teams on regulatory tasks.

Responsabilidades

• Develop and administer regulatory compliance program for BCC.
• Oversee study start-up, trial life-cycle and closeout at sponsor level.
• Maintain TMF/ISF management and regulatory documentation.
• Ensure adherence to GCP and applicable regulations across trials.
• Audit coordination, inspections, and responses to non-compliance.

Conocimientos

Regulatory compliance

Clinical trial experience

Project management

FDA/GCP knowledge

IRB/cIRB familiarity

Auditing

Cross-functional coordination

Educación

Master's Degree

Herramientas

Florence eBinder TMF/ISF

Descripción del empleo

The Beat Childhood Cancer Research Consortium (BCC) at the Penn State College of Medicine invites a remote, full-time Clinical Trial Regulatory Project Manager to oversee regulatory operations for 55+ hospital sites across the US, with a focus on compliance, documentation, and inspections.

Ideal candidates bring strong cIRB/IRB, FDA IND experience, and ability to coordinate multiple principal investigators and trials in a fast-paced environment. Remote with travel as needed.