Manager, Clinical Monitoring

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company’s customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies.

• Oversight and performance of Clinical Monitoring staff in accordance with internal KPIs.
• Lead, manage, and motivate a team of Clinical Monitoring staff to a standard consistent with Catalyst’s values and overall focus on quality.
• Develop evaluation processes, perform gap analysis, and ensure all clinical staff are properly trained to perform their duties consistent with Catalyst’s quality standards.
• Work in collaboration with Clinical Monitoring Leadership to define department targets for Clinical Monitoring staff and ensure proper monitoring expectations.
• Participate in resource management, including Clinical Monitoring staff resourcing to projects, participation in interviewing and hiring decisions, and review of utilization and billing practices to ensure alignment with project budgets.
• Support the development and maintenance of Clinical Monitoring project deliverables as needed.
• Provide support for site audits/inspections and follow audit/inspection findings to resolution as it relates to involved Clinical Monitoring staff.
• Periodic review of Monitoring reports to ensure quality oversight as needed.
• Implement functional standards, goals, and expectations with Clinical Monitoring staff and serve as mentor.
• Ensure training of and compliance with appropriate Catalyst and/or sponsor SOPsli>
• Complete Clinical Monitoring staff onboarding and offboarding as appropriate.
• Drive process improvements across Oncology line of the business.
• Other ad hoc responsibilities as required.

• 2+ years of management or oversight within pharmaceutical or CRO industry.
• 1-2 years of Lead CRA/Clinical Trial Manager experience in the pharmaceutical or CRO industry.
• 4+ years of CRA experience in the pharmaceutical or CRO industry.

• Strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials.
• Proficient with Microsoft Office Suite.
• Excellent written and oral communication skills.
• Excellent presentation skills.
• Strong organizational, problem‑solving, and analytical skills.
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Strong interpersonal skills.
• Ability to deal effectively with a diversity of individuals at all organizational levels.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Ability to work independently and as a member of various teams and committees.
• Good judgement with the ability to make timely and sound decisions.
• Ability to travel up to 25%.
• Ability to work remotely and manage a remote team.

Sedentary work that primarily involves sitting/standing. Employee may be office or home based with regular business travel.