Job Description
Precision for Medicine is hiring a Director, Clinical Monitoring, the position is working remotely in Poland.
Position Summary:
Responsibilities are focused on the management and career development of the organization’s GCM workforce located in a region/area/therapeutic area as well as leading the development of departmental initiatives to strengthen the quality and productivity of GCM operations. The Director GCM is responsible for financial and quality aspects of the assigned GCM hierarchy. Will lead, manage, and motivate a team of GCM staff 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 and staff achieve the required levels of quality and productivity. In addition, this position will provide the GCM staff 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:
· 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, TE, 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
Qualifications:
Minimum Required:
· Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline
Other Required:
· 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 superviso ... (truncated, view full listing at source)