Oversight Monitor

12 month renewable contract

Salaried Role

Fully Remote while not traveling

up to 50% travel

Looking for a Senior Level Oversight Monitor/Manager

Job Title: Oversight Monitor

Job Description

The Oversight Monitor provides independent oversight of clinical monitoring activities performed by Contract Research Organizations (CROs) and/or third-party vendors. This ensures compliance with ICH-GCP (E6 R2/R3), applicable regulatory requirements, and the sponsor’s Quality Management System (QMS). The role 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 a risk-based Monitoring Oversight Plan.
• Implement risk-based quality oversight strategies in alignment with the Monitoring Oversight Plan and Quality Risk Management Plan.
• Evaluate protocol-specific risks related to patient safety, data quality, and site operations.
• Verify that CRO(s) and CRAs follow appropriate risk identification and mitigation measures.
• Maintain oversight documentation, Monitoring Oversight Visit reports, and issue-tracking logs per SOP requirements.
• 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 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

• 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 oversight visits as a Lead CRA or OM.
• 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.
• Neurology experience required.
• Experience with Veeva Vault CTMS.

Additional Skills & Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field (advanced degree preferred).
• Prior experience in CRO/vendor management is strongly preferred.
• Experience overseeing eCOA/ePRO vendors preferred.
• Ability to travel for oversight visits nationally in the USA (approximately 70%).
• Excellent communication, organizational, and problem-solving abilities.

Work Environment

The position is remote, offering flexibility and the opportunity to work from anywhere. Regular travel for oversight visits within the USA is required.

This is a Contract position based out of Plymouth Meeting, PA.

The pay range for this position is $76.00 - $76.00/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)

This is a fully remote position.

This position is anticipated to close on Apr 10, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $76