Manager, Clinical Research Monitoring

Job Summary

The Manager, Clinical Research Monitoring (CRM) will lead a team of CRAs and Clinical Research Coordinators (CRCs), working with the broader Clinical Operations team to ensure trials are executed on time, on budget, and in full compliance with FDA, GCP, and all other regulatory requirements. The Manager, CRM will mentor CRAs, optimize monitoring strategies, and collaborate with Clinical Program Managers (CPGMs) and Clinical Project Managers (CPMs) to ensure overall quality and timeliness of clinical deliverables for studies.

Job Details/Responsibilities

Main responsibilities

• 50%: Lead, coach, and mentor a team of CRAs and CRCs, fostering accountability, collaboration, and professional growth.
• 15%: Oversee site monitoring activities to ensure compliance with study protocols, standard operating procedures (SOPs), and regulatory guidelines.
• 15%: Advise the team on study site issues and ensure corrective actions are taken for protocol or regulatory deviations.
• 10%: Develop and manage clinical study monitoring programs in collaboration with CPGMs and CPMs.
• 10%: Partner with Clinical Quality Assurance (CQA) to prepare for audits and inspections and monitor potential quality risks.
• Follow all established Environmental Health & Safety and Quality System policies and practices, including those concerning product and patient safety, associates, the environment, and the community.

Organizational Impact

• Guide the operational execution of clinical trials through site monitoring strategies, resource planning, and budget input.
• Help keep studies aligned with company objectives, quality standards, timelines, and financial expectations.
• Forecast CRA and CRC staffing needs based on current and anticipated studies.
• Develop clinical trial budget inputs that reflect study complexity, monitoring requirements, staffing, and site and vendor activities.
• Manage CROs and consultants, when required, to ensure contracted work is planned, monitored, and delivered.
• Partner with CPGMs and CPMs to align timelines, milestones, enrollment, monitoring activities, and operational priorities.

Communication & Influence

• Direct CRAs and CRCs on study priorities, monitoring expectations, timelines, quality requirements, and operational goals.
• Set expectations, clarify responsibilities, evaluate performance, and provide constructive feedback.
• Coordinate with CPGMs and CPMs on timelines, resources, monitoring strategy, and risk mitigation.
• Escalate issues and risks to leadership with supporting facts, impact assessments, and recommendations.
• Report monitoring metrics and key performance indicators, explaining trends and their implications for study performance.

Innovation & Complexity

• Analyze monitoring trends, performance data, site issues, and emerging risks to assess their impact on quality, timelines, compliance, and operations.
• Recommend actions to project teams and clinical leadership, including when an issue requires escalation or a change in strategy.
• Lead process improvements by identifying recurring problems, evaluating root causes, implementing solutions, and assessing results.
• Guide CRAs and CRCs through ambiguous site issues while balancing protocol requirements, company procedures, regulations, and study objectives.

Leadership & Autonomy

• Directly supervise the CRA and CRC team, manage workloads and priorities, and monitor assigned deliverables.
• Coach and mentor team members, identify training needs, share best practices, and support professional development.
• Independently manage day-to-day personnel and clinical operations decisions within established policies, budgets, and study requirements.
• Determine workload allocation, monitoring priorities, resource needs, and responses to team and site issues.
• Escalate significant risks, performance concerns, and resource constraints, providing analysis and recommendations when decisions require broader approval.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Good interpersonal skills, self-motivated and retain a positive attitude
• Proven ability to mentor and develop high-performing teams
• Excellent problem solving, judgment and decision-making skills
• Effective oral/presentation and written communication skills

• Excellent project management skills (including budgeting and forecasting skills)
• Proficiency with Microsoft Suite (e.g., Outlook, Project, Visio, Excel, Word etc.)
• Proficient with clinical trial management systems (CTMS) and electronic data capture (EDC) platforms.
• Strong organizational skills with the ability to manage multiple priorities simultaneously.
• Excellent communication and relationship-building skills with both internal teams and external stakeholders.
• In-depth knowledge of IDEs for PMA & 510(k)s, PMCF studies, and studies to support both domestic and global approvals.
• In-depth knowledge of GCP, FDA regulations, international regulations and clinical trial processes.
• Ability to work in a highly matrixed team environment

Qualifications/ Background Experiences

• Bachelor's degree in life sciences, nursing, or a related field required, advanced degree preferred and minimum 6 years clinical research experience, including site monitoring experience, with at least 2 years of people management experience; or an equivalent combination of education, training, and relevant work experience. Medical device experience preferred
• Certification to Clinical Professional Societies strongly preferred

• Experience with site and/or sponsor level audits or FDA BIMO inspection(s) required.