Manager / Senior Manager, Clinical Monitoring

Due to continued growth, Precision for Medicine are hiring!  We have open opportunity due to continued growth. We are looking for a a experienced line manager of CRAs, to join our Global Clinical Monitoring team in Europe.

This is a remote based role in Spain, with occasional travel for co-monitoring  and QA visits as needed.

Position Summary:

The Manager / Senior Manager, Global Clinical Monitoring (GCM) is responsible for the management and career development of the our Clinical Research Associate (CRA) workforce, as well as supporting the development of departmental initiatives to strengthen the quality and productivity of GCM operations.

This position requires the ability to independently lead, manage, and motivate a team of CRAs (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. Specific focus will be to ensure the right resources are assigned to projects and that those resources have the tools necessary to be successful. In addition, this position will provide the CRAs with career development and support, to minimize turnover and maintain high levels of employee satisfaction

 

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.

· Perform other duties as assigned by Leadership

Qualifications:

· Graduate, postgraduate or equivalent experience ideally in a scientific or healthcare discipline

Other Required:

· Strong experience in clinical operations, either in CRO or Pharmaceutical industry with a previous broad onsite monitoring experience.

· Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records.

· Previous experience of direct supervisory experience, managing CRAs, including:

      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%.

· Experience in Oncology would be desirable

 

Competencies:

· Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements, relevant Precision for Medicine