Manager, Global Clinical Monitoring

The Manager Global Clinical Monitoring (GCM) offers an additional development path for clinical research professionals. Responsibilities focus on the management and career development of the organization’s Clinical Research Associate (CRA) workforce and supporting departmental initiatives to strengthen the quality and productivity of GCM operations. Responsibilities Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual, team, and departmental goals. Assist with and contribute to project resourcing to ensure proper level and allocation of resources is assigned for each project within the hierarchy, and update tracking systems and interface with project teams. Collaborate with Clinical Team Leads, Clinical Trial Managers, and the 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, and assist CRAs with project-specific issues. Identify quality risks and issues and recommend corrective action plans to the leadership team to address deficiencies in employee performance. 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 collaborate with the Clinical Operations Management Team on the evaluation of these metrics. Participate in the interview process for new CRAs by reviewing CVs and conducting interviews. Conduct onboarding 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. Assist with the planning, assigning, and directing of work and gather performance feedback to contribute to appropriate action plans. Perform other duties as assigned by leadership. Qualifications Graduate, postgraduate, 4‑year college degree, or equivalent experience ideally in a scientific or healthcare discipline. Other Required At least 7 years in clinical operations, data management, or related discipline (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, 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%. Preferred Experience in the therapeutic area/country of the staff assigned to manage. Skills Mastery knowledge of ICH‑GCP, applicable local regulatory requirements, relevant Precision for Medicine SOPs, technical CRA knowledge of all study phases (including remote monitoring and clinical data review) and regulatory guidance. High capacity for emotional intelligence and a passion for people management and development. Ability to develop training plans and hold personnel accountable to training goals or addressing training needs. Deep knowledge of how clinical research centers operate and ability to teach CRAs to solve site and execution-related problems at the site level. Understanding and ability to work with EMRs and EDCs. High self‑motivation and ability to work independently as well as in a team environment. Motivates other members of the project team to meet timelines and project goals. Highly organized, ability to set priorities, and possesses excellent problem‑solving skills. Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective. Understanding of clinical trials methodology, including a working knowledge of protocols and indications being studied. Ability to develop, coach and mentor CRA staff. High degree of professionalism, punctuality, and understanding of service culture and positive interactions with customers and teammates, including good interpersonal skills. Communication skills both verbally and in written form. Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency. Practical knowledge of IT tools and systems used on project teams. Values system and work ethic consistent with Precision Values and Company Principles. Salary Range : $121,800 - $182,600 USD Benefits : discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, paid time off for sick leave and vacation, among other benefits. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. #J-18808-Ljbffr Precision Medicine Group