Manager, Global Clinical Monitoring (CRA Line Manager)

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

Due to our continued growth we are now seeking a Manager, Global Clinical Monitoring.

As a Manager within our CRA Group, you will be responsible for leading, managing, and motivating a team of CRAs to a standard consistent with Precision for Medicine’s values and overall focus on quality. As well as oversight for CRAs, you will also be responsible for the career development of the organization’s Clinical Research Associate (CRA) workforce as well as supporting the development of departmental initiatives to strengthen the quality and productivity of operations within the group.

Essential functions of the job include but are not limited to:

• Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals.
• Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project within their hierarchy (with respect to project phase). Update tracking systems and interface with project teams.
• Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately.
• Develop, mentor, manage and coach CRA staff to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability.
• Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues.
• Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees.
• Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.
• Ensure CRAs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
• Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency and efficiency in execution.
• Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics.
• Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process.
• Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training and other functional areas.
• Represent Precision for Medicine in a professional manner • Manage CRA staff in accordance with Precision for Medicine’s values and policies.
• Secondary responsibilities include assisting with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans.

The ideal candidate will have:

• Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline
• Extensive experience in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry, with a minimum of 5 years onsite monitoring experience. Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records.
• 3-5 years of direct supervisory experience managing CRAs
• Experience creating effective development programs for clinical staff.
• Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision for Medicine quality standards
• Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.