FSP Manager, Global Clinical Monitoring at Precision Medicine Group

, , United States -

Full Time

Start Date

Immediate

Expiry Date

03 Mar, 26

Salary

163800.0

Posted On

03 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Team Management, Career Development, Quality Assurance, Project Coordination, Emotional Intelligence, Training Development, Problem Solving, Clinical Trials Methodology, Interpersonal Skills, Communication Skills, Regulatory Compliance, Resource Allocation, Metrics Development, Site Monitoring, Performance Evaluation

Industry

Pharmaceutical Manufacturing

Description

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 Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $121,000—$163,800 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. 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. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Responsibilities

The FSP Manager oversees the management and career development of Clinical Research Associates (CRAs) while ensuring high-quality delivery of project activities. This role includes generating action plans, mentoring staff, and collaborating with various teams to meet resource needs and site requirements.