Oversight Manager

Mallinckrodt Pharmaceuticals•Malvern, PA

2d•Remote

About The Position

The Oversight Manager is responsible for evaluating the quality of monitoring activities associated with clinical studies to ensure the protection of human subjects, adherence to study protocols, and compliance with regulatory requirements. This role also identifies, recommends, and implements corrective and preventive actions when necessary. The Oversight Manager gathers and incorporates site feedback on all aspects of study operations, ensures sites are inspection-ready, and fosters strong working relationships with investigative sites. In collaboration with Clinical Operations, this role supports the identification of sites for Monitoring Oversight Visits (MOVs) and conducts comprehensive oversight activities, including the evaluation of monitoring quality and CRA (Clinical Resource Associations) performance.

Requirements

Bachelor’s degree, RN, or higher in a scientific or healthcare-related field preferred.
Minimum of 3 years of clinical monitoring experience.
Minimum of 5 years of experience in the pharmaceutical industry or at a clinical research site.
Prior experience mentoring and/or training Clinical Research Associates (CRAs).
Proven experience developing and delivering training programs.
Strong knowledge of Good Clinical Practice (GCP) and applicable FDA regulations.
Comprehensive understanding of clinical trial monitoring domestically.
Working knowledge of cross-functional processes and site-level operations.

Nice To Haves

Excellent written and verbal communication skills, with the ability to present to diverse audiences.
Proficiency with clinical trial systems and tools (e.g., EDC, CTMS, eTMF, IRT) and Microsoft Office applications.
Experience with Veeva Vault Clinical strongly preferred.
Ability to work independently with minimal supervision while contributing to long-term organizational goals.
Strong organizational, planning, and multitasking skills.
Proactive communicator with the ability to engage effectively across all levels internally and externally.
Demonstrated problem-solving skills with the ability to anticipate challenges and implement effective solutions.
Proven ability to build and maintain collaborative relationships across teams, partners, and external vendors.

Responsibilities

Identify and select sites for Monitoring Oversight Visits (MOVs) in collaboration with Clinical Operations.
Conduct MOVs, including but not limited to: Review of source data verification (SDV) completed by CRAs, Investigational product (IP) accountability checks, Review of CRA queries and monitoring activities, Assessment of Investigator Site Files (ISF), Meetings with site staff.
Evaluate the overall quality of monitoring and CRA performance.
Document findings and complete comprehensive MOV reports.
Author and maintain study-specific Monitoring Oversight Plans.
Identify, escalate, and support resolution of quality and compliance issues.
Partner with study teams and sites to ensure inspection readiness.
Collaborate with cross-functional teams to implement process improvements.
Perform Trial Master File (TMF) quality control checks.
Review monitoring trip reports in accordance with oversight plans.
Assist in the development of Standard Operating Procedures (SOPs) related to oversight activities.
Develop and conduct training programs to enhance monitoring and vendor performance.
Design and implement tools and resources to improve monitoring effectiveness.
Develop training materials and tools for audit and inspection preparation.