Precision For Medicine

Manager, Global Clinical Monitoring

Precision For Medicine

full-time

Posted on:

Origin:  • 🇺🇸 United States

Visit company website
✨ AI Apply
Apply

Salary

💰 $113,900 - $170,900 per year

Job Level

SeniorLead

Tech Stack

Google Cloud Platform

About the role

  • Manage and develop the organization’s Clinical Research Associate (CRA) workforce and support departmental initiatives to strengthen quality and productivity of GCM operations
  • 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
  • Ensure the right resources are assigned to projects and that those resources have the tools necessary to be successful
  • 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
  • Collaborate with Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure resource needs and site requirements are met
  • Develop, mentor, manage and coach CRA staff to progress their skills and advocate individual career development
  • Perform accompanied site visits to assess CRA skills and developmental needs, and assist CRAs with project specific issues
  • Identify quality risks and issues and recommend corrective action plans to leadership team
  • Ensure staff have the proper resources, training, materials, and access to systems to deliver on position expectations
  • Ensure CRAs provide timely and accurate updates of all required administrative material on company systems
  • Work with Clinical Operations Management Team to continually improve CRA expectations and procedures
  • 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 and conduct CV review and interviews
  • Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training and other functional areas
  • Represent Precision for Medicine professionally and manage CRA staff in accordance with company values and policies
  • Assist with 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
  • 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%
  • Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements, relevant Precision for Medicine SOPs, 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
  • 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 is able to 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