Manager, Global Clinical Monitoring

March 19

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Precision For Medicine

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Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

Global Clinical Trial Services • Specialty Lab Services • Translational Science • Clinical Data Management • Biostatistics

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

📋 Description

• The Manager Global 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. 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.

🎯 Requirements

• Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline • 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 • 3-5 years of direct supervisory experience managing CRAs 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

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance and disability benefits • Parental leave • Paid time off for sick leave and vacation