Contract Clinical Monitoring Oversight Lead

Contract Clinical Monitoring Oversight Lead - Contract - Onsite

Proclinical Staffing is seeking a Contract Clinical Monitoring Oversight Lead to join a clinical-stage biotech company. This is a contract role located in Philadelphia, PA.

Primary Responsibilities

The Contract Clinical Monitoring Oversight Lead (CMOL) will be responsible for the oversight of investigator site and monitoring quality. The CMOL will be accountable for identifying monitoring performance issues and responsible for ensuring appropriate corrective and preventative actions are put in place. The Contract Clinical Monitoring Oversight Lead will report directly to the Head of Clinical Operations.

Skills & Requirements:

• Bachelor's degree or higher in Life Sciences, or Project Management
• Minimum of 8 years of Clinical Operations experience required with at least 6 years of experience at a CRO and/or pharmaceutical/biotech organization
• Oncology drug development experience is essential. Phase II/III clinical trial management and experience in cancer trials is highly desirable
• Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices (GCP), ICH and applicable Standard Operating Procedures
• Excellent organization skills; capable of managing complex processes in a punctual manner
• Must have demonstrated the ability to work independently
• Analytical Thinking- collects and researches data; uses intuition and experience to complement data.
• Problem Solving - identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions.
• Ethical- works with integrity and ethically.
• Innovation- displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas; presents ideas and information clearly and in a manner that gets others' attention.
• Planning/Organizing- uses time efficiently; able to manage and appropriately prioritize responsibilities.
• Quality- demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; monitors own work to ensure quality.

The Contract Clinical Monitoring Oversight Lead will:

• Oversees monitoring quality, regulatory and GCP compliance
• Conducts and reports oversight activities at investigator sites according to the monitoring oversight plan, both remote and onsite visits, as applicable
• Performs additional oversight visits/reviews based on the type of issues that arise during a study; visits may be conducted with the assigned monitor/CRA or alone depending on the nature of the issue(s)
• Works with CRO monitors/CRAs and other CRO colleagues to drive resolution of oversight issues
• Identifies site and monitor/CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of CAPAs to address these
• Shares site quality and trends, including preventive actions, across studies and program(s) to drive accelerated drug delivery
• Maintains a thorough knowledge and understanding of therapeutic area, assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality

If you are having difficulty in applying or if you have any questions, please contact Jenny Martin at (+1) 267-281-1277 or j.martin@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDCR