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Beacon Hill · 4 weeks ago

Clinical Monitoring Oversight Manager

United States

Contract

Hybrid

Senior Level

$70/hr - $80/hr

6+ years exp

Beacon Hill is seeking a Clinical Monitoring Oversight Manager responsible for overseeing Contract Research Organizations' monitoring activities to ensure high standards of data quality and compliance. This role involves collaborating with CROs and internal teams to identify risks, streamline processes, and implement best practices in clinical operations.

Staffing Agency

Hiring Manager

Phil Schneider

Responsibilities

Conduct monitoring quality oversight visits across all clinical studies in North America to ensure compliance with study protocols, regulatory guidelines, and company policies

Develop and implement comprehensive monitoring quality oversight plans tailored to specific studies, aligning objectives with organizational goals and timelines

Review and assess monitoring plans for each study to ensure robustness and adherence to best practices

Evaluate monitoring reports prior to oversight visits, identify potential issues or trends, and develop action plans to resolve non-compliance or data quality concerns

Provide expert guidance to clinical operations 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 mitigation strategies to uphold data integrity

Stay current on regulatory requirements, guidelines, and industry best practices, ensuring effective implementation and advising on necessary changes

Assist in developing and maintaining Standard Operating Procedures (SOPs) related to monitoring oversight, ensuring compliance across all studies

Collaborate with CRO monitors to ensure effective management of monitoring activities while maintaining quality standards and fostering transparent partnerships

Track monitoring report review metrics and compliance to drive continuous improvement

Lead training initiatives for study teams and service providers to ensure clear understanding of monitoring practices and expectations

Prepare and present findings from oversight activities to senior management, providing insights and recommendations for quality enhancement

Identify and implement process improvements within the monitoring oversight function to promote efficiency and compliance

Monitor adherence to corrective and preventive action plans following oversight visits

Coordinate with quality assurance teams to support audits and inspections, ensuring documentation and processes meet required standards

Qualification

Clinical OperationsGCPICH standardsFDA/EMA guidelinesCRO managementOncology experienceAnalytical skillsMS Office proficiencyCommunication skillsOrganizational skills

Required

Bachelor's Degree in life sciences or equivalent combination of education, training, and experience

Minimum 6 years of relevant experience in biotech or pharmaceutical industry, including at least 3 years focused on monitoring oversight

At least 3 years of experience in oncology

Strong knowledge of Clinical Operations, GCP, ICH standards, and FDA/EMA guidelines

Proven experience managing CRO relationships and overseeing monitoring activities

Self-motivated and able to take ownership of tasks with strong follow-through

Results-oriented team player with excellent collaboration and relationship-building skills

Exceptional analytical skills with the ability to assess data and trends effectively

Strong judgment and decision-making abilities

Ability to adapt to change in a dynamic, fast-paced environment

Excellent communication and interpersonal skills

Strong organizational skills and attention to detail, with ability to manage multiple projects and deadlines

Proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Adobe Acrobat), clinical trial management systems, and data management tools; experience with Smartsheet is a plus

Ability to travel up to 80%