Remote Regulatory Project Manager for Clinical Trials

The Pennsylvania State University; United States; Remote; USD 81,000 - 122,000; Full time

Benefits offered by this job

75% tuition discount

Comprehensive benefits package

Job summary

The Beat Childhood Cancer Research Consortium at Penn State College of Medicine seeks a full-time Clinical Trial Regulatory Project Manager to lead regulatory compliance across 55+ sites and 10+ trials. The role focuses on study start-up, lifecycle management, and document control, with a remote work arrangement and some travel.

Ideal candidates have a Master’s degree with 6+ years in regulatory affairs for clinical trials, knowledge of FDA IND, GCP and IRB processes, and strong communication

Qualifications

• Masters degree with 6+ years of relevant experience, or an equivalent combination
• Experience with regulatory compliance in clinical trials (FDA, GCP, ICH) and regulatory submissions
• Experience coordinating multiple sites, investigators and trials across a network

Responsibilities

• Develop and administer regulatory compliance program for the Beat Childhood Cancer Research Consortium (BCC)
• Provide guidance for regulatory documentation maintenance and management of regulatory processes
• Oversee Study Start-up, Trial Life-cycle, and Study Closeout at Sponsor level regulatory responsibilities and maintain eBinder TMF/ISF management
• Develop and implement compliance programs with ongoing analysis, interpretation and action plans
• Interpret and stay updated on federal and state regulations affecting regulatory compliance
• Maintain compliance with Good Clinical Practice throughout the trial life cycle
• Train and mentor staff; liaison between senior management and sites about regulatory issues
• Serve as a resource for study teams and investigators on regulatory inquiries
• Direct internal/external audits and respond to non-compliance findings at executive level
• Develop relationships with staff, collaborators, regulators as needed
• Adapt to fast-paced environments and changing circumstances
• Experience with cIRB/IRB, GCP, and FDA IND requirements preferred
• Ability to collaborate with multiple PIs and trials across sites

Skills

Regulatory compliance

Clinical trial management

GCP

FDA IND requirements

IRB/cIRB experience

Regulatory documentation

Education

Master's Degree in a relevant field

Tools

Florence eBinder TMF/ISF

Job description

The Beat Childhood Cancer Research Consortium at Penn State College of Medicine seeks a full-time Clinical Trial Regulatory Project Manager to lead regulatory compliance across 55+ sites and 10+ trials. The role focuses on study start-up, lifecycle management, and document control, with a remote work arrangement and some travel.

Ideal candidates have a Master’s degree with 6+ years in regulatory affairs for clinical trials, knowledge of FDA IND, GCP and IRB processes, and strong communication