Monitoring Quality Oversight Manager

Monitoring Quality Oversight Manager

Remote!

Small Biotech

Must support west coast hours!

Job Description

As a Monitoring Quality Oversight Manager, you will be responsible for the oversight of the Contract Research Organizations (CROs) monitoring activities to ensure the highest standards of data quality and compliance within clinical operations. This role involves a proactive approach to monitoring oversight, including collaboration with CROs and internal teams to identify and mitigate risks, streamline processes, and implement best practices.

Responsibilities

• Conduct monitoring quality oversight visits across all clinical studies in North America to ensure compliance with study protocols, regulatory guidelines, and company policies.
• Generate and implement comprehensive monitoring quality oversight plans tailored to specific studies, aligning objectives with organizational goals and project timelines.
• Review and assess monitoring plans for each study, ensuring they are robust, comprehensive, and reflective of best practices in clinical monitoring.
• Evaluate monitoring reports in preparation for oversight visits, identify potential issues or trends and develop appropriate action plans for resolution to address any non-compliance or data quality concerns.
• Provide expert guidance and support to clinical operations study teams and service providers on monitoring-related matters, including but not limited to protocol deviations, adverse events, and data quality assessments.
• Conduct risk assessments regarding monitoring activities and develop risk mitigation plans to uphold the quality and integrity of clinical trial data.
• Stay updated on regulatory requirements, guidelines, and industry best practices related to monitoring oversight, ensuring their effective implementation within the organization and advising on necessary changes.
• Assist in the development and maintenance of Standard Operating Procedures (SOPs) related to monitoring oversight, ensuring adherence and compliance across all studies, and updating them as necessary.
• Collaborate with CRO monitors to ensure effective management of monitoring activities while adhering to quality standards and fostering a strong, transparent partnership.
• Maintain tracking of clinical operations monitoring report review metrics and compliance to ensure continuous improvement in monitoring oversight.
• Lead training and development initiatives for study teams and service providers to ensure a clear understanding of monitoring practices, responsibilities, and expectations.
• Prepare and present findings from monitoring oversight activities to senior management, providing insights and recommendations for enhancing the overall quality assurance framework.
• Identify potential areas for process improvement within the monitoring oversight function, implementing changes that promote efficiency, effectiveness, and compliance.
• Monitor adherence to action plans developed during oversight visits and ensure proper follow-up on corrective and preventive actions.
• Coordinate with the quality assurance team to support audits and inspections, ensuring that all documentation and processes meet required standards.

Essential Skills

• Bachelor’s Degree in life science or equivalent combination of education, training, and relevant experience.
• Minimum 6 years of relevant experience in biotech or pharmaceutical industry, with at least 3 years focusing on monitoring oversight.
• At least 3 years of experience in oncology.
• Experience in Clinical Operations and a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines.
• Proven experience in managing CRO relationships and overseeing monitoring activities.
• Strong understanding of clinical trial processes.
• Exceptional analytical skills, with the ability to assess data and trends effectively.
• Excellent communication and interpersonal skills, with the ability to provide clear guidance and support to cross-functional teams.
• Demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Adobe Acrobat), clinical trial management systems, and data management tools.

Additional Skills & Qualifications

• Self-motivated, with initiative and able to take ownership of, and follow through with, specific tasks.
• Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships.
• Ability to exercise good judgment and make decisions that are appropriate for the organization.
• Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment.
• Analyze and triage problems, prioritize accordingly, and propose solutions.
• Strive for continuous improvement and embrace innovative ideas in daily work.
• Strong organizational skills and attention to detail, with the ability to manage multiple projects and deadlines.
• Experience with Smartsheet is a plus.

Work Environment

This is a remote position with hours based on Pacific Standard Time (PST).

This is a Contract position based out of San Diego, CA.

The pay range for this position is $90.00 - $115.00/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 Mar 10, 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 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 for other accommodation options.

Salary : $90 - $115