Precision for Medicine is growing! We are hiring Manager, Clinical Monitoring to join our European team. The position could be covered fully remotely from the UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia.
The Manager Clinical Monitoring (GCM) offers an additional development path for clinical research professionals. Responsibilities are focused on the management and 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 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. 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. 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.
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.
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.
Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline.
~ Fluent in English and French
~ At least 7 years or more 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.
~ Strong monitoring experience in oncological clinical trials.
~o 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%.
Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements, relevant Precision for Medicine SOPs, technical CRA knowledge of all phases of study (including remote monitoring and clinical data review) as well as regulatory guidance.
High capacity for Emotional Intelligence and a passion for people management and development.
As part of overall line management responsibilities, ability to develop training plans and hold personnel accountable to achieving training goals or addressing training needs
Deep knowledge of how clinical research centers operate along with the ability to teach CRAs to solve site and execution related problems at the site level.
Motivates other members of the project team to meet timelines and project goals.
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