FSP Manager, Global Clinical Monitoring

Position Summary:

• The FSP 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 providing oversight and coordination of project activities for CRAs assigned to FSP partnership.
• This position requires the ability to independently lead, manage, and motivate a team of CRAs to a standard consistent with Precision for Medicine’s values and overall focus on quality. 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 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.

Qualifications:
Minimum Required:

• Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline

Other Required:

• 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%.

Preferred:

• Experience in the Therapeutic area/country of the staff assigned to manage.

Skills/Competencies:

• 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