Senior Manager Quality Monitoring Oversight

Job Title: Senior Manager, Monitoring Quality Oversight Job Description The Senior Manager, Monitoring Quality Oversight is responsible for leading monitoring quality oversight across multiple clinical studies, supporting the Clinical Operations team in the effective execution of clinical trials. This role oversees Contract Research Organization (CRO) monitoring activities to ensure the highest standards of data quality, regulatory compliance, and operational excellence. The position requires a proactive, strategic approach to monitoring oversight, close collaboration with CROs and internal teams, and a strong background in clinical operations, particularly within oncology and pharmaceutical environments. Responsibilities Conduct monitoring quality oversight visits across clinical studies in North America to verify compliance with study protocols, regulatory guidelines, Good Clinical Practice (GCP), and internal policies. Generate and implement comprehensive monitoring quality oversight plans tailored to individual studies, ensuring alignment with organizational goals and project timelines. Review and assess monitoring plans for each study to confirm they are robust, comprehensive, and consistent with best practices in clinical monitoring. Evaluate monitoring reports in preparation for oversight visits, identify potential issues or trends, and develop appropriate action plans to address non-compliance or data quality concerns. Provide expert guidance and support to clinical operations study teams and service providers on monitoring-related matters, including protocol deviations, adverse events, and data quality assessments. Conduct risk assessments related to monitoring activities and develop risk mitigation plans that protect the quality and integrity of clinical trial data. Stay current with regulatory requirements, guidelines, and industry best practices related to monitoring oversight, and ensure their effective implementation across studies. Assist in the development, maintenance, and continuous improvement of Standard Operating Procedures (SOPs) related to monitoring oversight, ensuring adherence and consistency. Collaborate closely with CRO monitors to manage monitoring activities effectively, maintain high quality standards, and foster a transparent, productive partnership. Maintain tracking of clinical operations monitoring report review metrics and compliance, using these data to drive continuous improvement in monitoring oversight. Lead training and development initiatives for study teams and service providers to clarify monitoring practices, responsibilities, and expectations. Prepare and present findings from monitoring oversight activities to Senior leadership, offering insights and recommendations to strengthen the overall quality assurance framework. Identify and implement process improvements within the monitoring oversight function to enhance efficiency, effectiveness, and compliance. Monitor adherence to action plans developed during oversight visits and ensure timely follow-up on corrective and preventive actions. Coordinate with the quality assurance team to support audits and inspections, ensuring documentation, processes, and monitoring activities meet required standards. Contribute to the growth of the clinical development pipeline by ensuring the quality and integrity of clinical trial data through rigorous oversight of CRO monitors. Essential Skills Strong background in clinical operations within the pharmaceutical or biotechnology industry. Proven experience overseeing CRO monitoring activities in clinical trials. In-depth knowledge of Good Clinical Practice (GCP), study protocols, and regulatory guidelines relevant to clinical research. Demonstrated expertise in monitoring quality oversight and data quality assurance. Strong analytical skills with the ability to identify trends, assess risks, and develop effective mitigation strategies. Experience working on oncology clinical studies. Ability to generate, review, and refine monitoring plans and monitoring quality oversight plans. Proven capability to interpret monitoring reports and translate findings into actionable improvement plans. Strong communication skills, with the ability to provide clear guidance to study teams, service providers, and Senior leadership. Ability to collaborate effectively with internal teams and external CRO partners. Experience contributing to or maintaining Standard Operating Procedures (SOPs) related to clinical monitoring and oversight. Additional Skills & Qualifications Experience in pharmaceutical or oncology-focused clinical development environments. Familiarity with risk-based approaches to monitoring and quality oversight. Experience supporting audits and inspections in a clinical operations or quality assurance context. Ability to design and deliver training related to monitoring practices and expectations. Strong organizational skills and attention to detail, with the ability to manage multiple studies and priorities concurrently. Strategic mindset with the ability to influence best practices and continuous improvement in monitoring oversight. Comfort working in a dynamic, growing pipeline environment with evolving processes. Interest in long-term engagement supported by a renewable contract structure. Work Environment This is a remote role aligned to Pacific Time (PST), offering flexibility while maintaining close collaboration with North America–based clinical studies and teams. The work involves regular virtual interaction with internal clinical operations staff, CRO monitors, and quality assurance colleagues, using standard digital communication and documentation tools. The position operates within a structured, process-driven clinical research environment that emphasizes regulatory compliance, data integrity, and continuous improvement. The renewable contract arrangement provides ongoing engagement and the opportunity to contribute to a growing clinical development pipeline over time. Job Type & Location This is a Contract position based out of South San Francisco, CA. Pay and Benefits The pay range for this position is $90.00 - $110.00/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 Aug 26, 2026. 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. 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 process due to a disability, please email [email protected] for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.