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Vice President, Clinical Trial Management

Company: Precision Medicine Group
Location: New York
Posted on: November 22, 2021

Job Description:

Position Summary

Provides overall leadership to the Clinical Operations Department and is responsible for the overall coordination of short-term and long-term activities. Collaborates with executive management on the ongoing development of the Clinical Operations Department and contributes to the business plan at both the tactical and strategic levels. Directly, and through subordinate managers, ensures that the planning, implementation, monitoring and management of clinical trials are in compliance with federal regulations, ICH Guidelines, Good Clinical Practices (GCPs) and SOPs.

Essential functions of the job include but are not limited to:

  • Work with Senior Leadership to support defined corporate and departmental business strategies for PfM
  • Direct, manage and ensure collaboration within a team of Directors and Clinical Trial Managers in the planning, execution and governance of clinical activities on a global platform
  • Provide leadership and oversight on all programs including large programs or programs that are increasingly complex (in scope, revenue contribution, volume and design)
  • Interact with Project Manager and/or DPM in the escalation and resolution of clinical study issues
  • Optimize the profitability of Clinical Operations to meet or exceed budget targets
  • Assess and manage resource allocations to ensure that established cost, time, and quality goals are met
  • Select, train, develop and manage the performance of talent in Clinical Operations
  • Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals and deliverables) to assigned Clinical Trial Managers
  • Identify and escalate impacts to project scope, resources, schedule or budget through standard methods
  • Ensure Clinical Operations personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
  • Participate with Business Development in opportunity development, proposals and budgeting, bid defense preparation and attendance
  • Understand and manage project/program inter-dependencies to achieve program milestones/deliverables
  • Conduct evaluations and implement required changes for all projects (including mid-project recovery of at risk projects, re-scoping, postponement, or cancellation)
  • Measure and report KPIs and lead continuous improvement
  • Recognize, exemplify and adhere to PFM's values that center on our commitment to quality, our people, clients and performance
  • Active in the general and strategic management of the business
  • Recognize, exemplify and adhere to PFM's values that center on our commitment to quality, our people, clients and performance
  • Manages workload of supervised staff with continued assessment and adjustment as needed
  • Provides on-going feedback, development and coaching of Clinical Trial Managers and above including annual performance reviews
    Qualifications

    Minimum Required:
    • Bachelor's degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred.
    • A minimum 15 years of experience in clinical research, including extensive clinical and line management experience or proven competencies for this position
    • Expert knowledge of GCP/ICH guidelines and the clinical development process
      Other Required
      • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
      • Excellent communication and interpersonal skills to effectively interface with others in a team setting
      • Excellent organizational skills, attention to detail, and a customer service demeanor
      • Experience in managing clinical aspects of complex and global trials
      • Ability to travel domestically and internationally including overnight stays
        Preferred
        • Advanced degree
          Competencies
          • Working knowledge of clinical operations tools and techniques
          • Direct work experience in a global, cross-functional clinical management environment
          • Proven experience in people management
          • Proven experience in strategic planning, risk management and change management
          • Ability to work closely with business unit leadership to understand customer's needs
          • Strong analytical skills and business acumen
          • Executive presence with ability to confidently deliver complex presentations to senior management or clients
          • High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective.
          • Demonstrated leadership track record and effective interpersonal skills
          • Ability to lead and inspire excellence within a team
          • Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
          • Results oriented, accountable, motivated and flexible
          • Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
          • Excellent presentation, verbal and written communications skills
          • In depth proven experience in pharmaceutical and/or device research required
          • Proven experience in delegating while fostering cohesive team dynamics
          • Demonstrated successful independent negotiation and conflict management strategies
            Any data provided as a part of this application will be stored in accordance with our Privacy Policy .

            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. -- 2020 Precision Medicine Group, LLC

            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 .

Keywords: Precision Medicine Group, New York , Vice President, Clinical Trial Management, Executive , New York, New York

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