Job Description

Job Title: Oversight MonitorJob Description

The Oversight Monitor provides independent oversight of clinical monitoring activities conducted by Contract Research Organizations (CROs) and third-party vendors. The role ensures compliance with ICH-GCP (E6 R2/R3), applicable regulatory requirements (such as FDA, EMA, Health Canada, MHRA), and the sponsor's Quality Management System (QMS). This position focuses on evaluating the quality, consistency, and adequacy of site monitoring, issue management, and documentation practices to ensure trial integrity, subject safety, and data reliability.

Responsibilities

• Provide continuous oversight of CRO-conducted monitoring activities to ensure compliance with the study protocol, Monitoring Plan, SOPs, regulatory and GCP requirements.

• Perform remote and on-site oversight visits to evaluate CRA performance and site quality.

• Review monitoring visit reports, follow-up letters, issue logs, and escalation processes to assess adequacy and timeliness.

• Track and trend CRO performance metrics and KPIs; identify systemic issues and areas for improvement.

• Support root cause analysis and CAPA development related to monitoring or site performance.

• Contribute to development and maintenance of risk-based Monitoring Oversight Plan.

• Implement risk-based quality oversight strategies in alignment with the sponsor's Monitoring Oversight Plan and Quality Risk Management Plan.

• Evaluate protocol-specific risks related to patient safety, data quality, and site operations.

• Verify that CROs and CRAs follow appropriate risk identification and mitigation measures.

• Maintain oversight documentation, Monitoring Oversight Visit reports, and issue-tracking logs per sponsor SOPs.

• Prepare and deliver periodic oversight summaries for leadership review.

• Ensure site inspection readiness and participate in inspections or audits as required.

• Provide feedback and guidance to CRO CRAs regarding quality expectations, data integrity, and GCP compliance.

• Collaborate with cross-functional teams (Clinical Operations, Data Management, QA, and Vendor Management) to support continuous improvement.

• Participate in oversight governance meetings and contribute to vendor performance reviews.

• Serve as the primary liaison between study sites and the sponsor.

• Build trusted partnerships with investigators and site staff to enhance collaboration and ensure site needs are recognized and met.

Essential Skills

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field (advanced degree preferred).

• Minimum 5-7 years of clinical research experience, including at least 3 years of on-site monitoring.

• Minimum 2 years of hands-on Monitoring Oversight experience including on-site monitoring oversight visits.

• Prior experience in CRO/vendor management or QA auditing is strongly preferred.

• Thorough understanding of ICH-GCP, E6 R2/R3, and applicable regional regulations.

• Demonstrated experience in inspection readiness and CAPA management.

• Strong analytical, documentation, and communication skills.

• Ability to travel for oversight visits (50-70%).

• Excellent communication, organizational, and problem-solving abilities.

Additional Skills & Qualifications

• Neurology experience preferred.

• Experience overseeing eCOA vendor preferred.

• Experience with Veeva Vault CTMS.

Work Environment

This is a remote position with one individual based in the East and another in the Mid-West/West. The company offers a collaborative team atmosphere with opportunities for growth and cross-functional collaboration. The role requires a quick learner who can hit the ground running, with the potential to take on additional responsibilities as the company grows.

Job Type & Location

This is a Contract position based out of Dallas, TX.

Pay and Benefits

The pay range for this position is $85.00 - $95.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Dec 31, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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