Senior Manager, Clinical Monitoring Oversight

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Accountable for the comprehensive management of clinical studies.

• Creating detailed QCO Plans in partnership with Clinical Trial Managers (CTMs).

• Assisting with study risk evaluations and establishing RBQM study requirements and strategies.

• Aiding in process excellence by upholding and consistently enhancing standard operating procedures.

• Delivering presentations on QCO roles and procedures to study teams and CROs.

• Supervising and assessing monitoring outputs such as Monitor Visit Reports and CTMS data.

• Conducting site visits, sharing findings, and acting as the primary contact for CROs.

• Executing gap analyses for both internal and external SOPs/processes.

⛳️ Requirements

• Bachelor's degree in a pertinent field.

• A minimum of 8 years of experience in clinical research monitoring.

• At least 5 years of clinical trial experience within a pharmaceutical, biotechnology, or CRO environment.

• Strong understanding of GCP regulations (e.g., US, EU, JP).

• Familiarity with risk-based monitoring strategies and tools (e.g., KRIs, QTLs, central monitoring).

• Proficient working knowledge of clinical systems: CTMS (e.g., Veeva Vault), EDC, eTMF, eCOA.

• Skilled in reviewing and interpreting clinical monitoring reports.

• Excellent written and verbal communication abilities.

🏝️ Benefits

• Equal opportunity employer committed to supporting individuals with disabilities and veterans.

• Reasonable accommodations available for applicants with disabilities.