Precision Medicine Group · 2 hours ago
FSP Manager, Global Clinical Monitoring
United States
Full-time
Remote
Mid, Senior Level
$121K/yr - $164K/yr
7+ years expPrecision Medicine Group is a leading organization in the healthcare sector, seeking an FSP Manager for Global Clinical Monitoring. This role focuses on managing and developing Clinical Research Associates while ensuring high-quality project oversight and team performance.
BiotechnologyHealth Care
Responsibilities
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
Qualification
Required
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%
Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements technical CRA knowledge of all phases of study (including remote monitoring and clinical data review) as well as regulatory guidance
High capacity for Emotional Intelligence and a passion for people management and development
As part of overall line management responsibilities, ability to develop training plans and hold personnel accountable to achieving training goals or addressing training needs
Deep knowledge of how clinical research centers operate along with the ability to teach CRAs to solve site and execution related problems at the site level
Demonstrates understanding and ability to work with EMRs and EDCs
Exhibits high self-motivation and can work and plan 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
Understands clinical trials methodology, including a working knowledge of protocols and indications being studied
Ability to develop, coach and mentor CRA staff
Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills
Communicates both verbally and in written form in an acceptable manner
Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency
Possesses practical knowledge of IT tools and systems in use on project teams
Values system and work ethic consistent with Precision Values and Company Principles
Preferred
Experience in the Therapeutic area/country of the staff assigned to manage
Benefits
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Mark Clein
Co-Founder & Chief Executive Officer
Matt DeZee
Chief Financial Officer
Company data provided by crunchbase