FSP Manager, Global Clinical Monitoring

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Precision Medicine Group

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Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

📋 Description

• 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 the FSP work order. Update tracking systems and interface with project teams. • Collaborate with the FSP Oversight Director 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 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. • Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics. • Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process. • Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training, and other functional areas, including sponsor specific training requirements. • Represent Precision for Medicine in a professional manner. • Manage CRA staff in accordance with Precision for Medicine’s values and policies. • Review and approve all visit reports, timecards, and expense reports for assigned CRAs. • Ensure monitoring visits are performed in accordance with monitoring plan. • Provide oversight of CRA project performance including eTMF completion and quality, SDV completion, and query/issue closure timeliness. • Attend investigator meetings and regular internal / sponsor meetings to discuss study progress and team performance. • Provide oversight of Study Start-up Team to ensure sites progress from selection to initiation visit on-time and in agreement with sponsor expectations. • Support CRAs and Study Start-up with ICF customization and version tracking. • Ensure study systems and trackers are kept up to date. • 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 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. • 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 • Disability benefits • Parental leave • Paid time off for sick leave and vacation