Director, Clinical Monitoring

Role Overview

• Ensure the development and implementation of action plans and provide developmental/strategic oversight to optimize GCM activities, with a focus on high quality delivery and productivity of individual/team/departmental goals
• Lead regional/therapeutic area project resourcing to ensure proper level and allocation resource is assigned for each project within a region/area
• 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 GCM Managers to progress their skills so that Precision for Medicine quality standards are maintained
• Advocate individual career development, and individual responsibility/accountability
• Oversee GCM quality performance within the assigned hierarchy and implement actions to correct negative trends
• Support the identification of quality risks and issues and recommend/implement 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 GCM staff within the assigned hierarchy 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
• Partner with Talent acquisition to ensure adequate levels of candidates and ad-hoc interview process to select high quality GCM staff
• Ensure appropriate on-boarding training for new GCM staff in conjunction with Human Resources, Clinical Training and other functional areas
• Represent Precision for Medicine in a professional manner
• Manage GCM 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

Requirements

• Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline
• At least 12 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
• 6+ years of direct supervisory experience managing CRAs and CRA Managers is expected in candidates for this position
• 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%

Benefits

• private medical insurance
• MultiSport Card
• life insurance
• pension
• home working allowance
• vacation
• discretionary annual bonus