Manager, Clinical Monitoring

As a Manager, Clinical Monitoring you are a key member of the Development Operations, Clinical Monitoring Team responsible for the line management of Clinical Research Associates. This includes professional development, mentoring, coaching, performance management including assessment visits, and resource management. Management duties will include oversight of both employee and consultant Clinical Monitoring staff. You will be responsible for quality delivery of the Clinical Monitoring portfolio through full performance management of Clinical Monitoring Staff.

Position Accountabilities/Responsibilities:

• Responsible for the oversight and performance of Clinical Monitoring staff in accordance with internal Key Performance Indicators (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.
• Perform CRA assessment visits on-site or remotely to assess and document overall CRA performance.
• 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 by not limited to Clinical Monitoring staff resourcing to projects, participation in interviewing and hiring decisions and review of utilization and billing practices to ensure resource alignment with project budgets.

• Support the development and maintenance of Clinical Monitoring project deliverables as needed.
• Provide support for site audits/inspections, as needed, 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 SOPs. Complete Clinical Monitoring staff onboarding and offboarding as appropriate. Drive process improvements across Oncology line of the business. Other ad hoc responsibilities as required.

Supervisory Requirements/Responsibilities:

Position will have management responsibilities. Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, performance appraisals, goal setting, & salary.

Position Qualifications and Requirements:

Experience:

• 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

Education: BS/BA Degree (or equivalent) in life sciences or certification in a related allied health profession from an appropriately accredited institution, such as nursing, medical or laboratory technology.

Required Skills:

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