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Director, Project Management

Company: AdvancedRPO
Location: Schenectady
Posted on: September 6, 2019

Job Description:

Overview Summary of Responsibilities

The Director, Project Management (PM), is responsible for the strategic and tactical operations of the PM department and serves as department head. The Director effectively manages all aspects of project management, including hiring, training, coaching PM staff as well as meeting all time frames and targets to both internal and external (Sponsors ) satisfaction. The role directs the scope of work, objectives, quality of deliverables, and other clinical activities of all CRO projects, which may be multi-regional in scope. He/She ensures appropriate communication channels are maintained and reporting schedules are adhered to by Project Managers. The Dir., PM ensures the development of project plans and key performance indices for all phases of the project lifecycle. Collaborates with Business Development to finalize project budgets and scope of work and oversees management of project budget(s) to meet departmental and corporate financial goals, proactively ensuring adherence.
Responsibilities Essential Functions

Managerial Responsibilities

  • Understand the Advanced Clinical overall financial plan and contribution to support Advanced Clinical s overall financial goals.
  • Maximize productivity to exceed AC budget goals.
  • Identify possible improvements to current processes, determine new processes that are needed, and initiate a plan to improve or develop said processes.
  • Train, mentor, monitor, and supervise Project Managers and other appropriate clinical personnel as necessary.
  • Coordinate PM assignments across projects to ensure all targets and deadlines are met
  • Conduct annual and semi-annual evaluations for direct reports.
  • Write training and establish training programs for PMs on new processes.
  • Participate in recruitment and selection of PMs
  • Standard Operating Procedures (SOPs)
    • Be familiar with and follow department SOPs.
    • Ensure staff is adequately trained on and following SOPs.
    • Create and review SOPs to recognize and prevent potential regulatory issues Business Development
      • Assist with RFP/RFI completion
      • Attend sales meetings as requested by Business Development Responsibilities
        • As needed, participate in or take responsibility for clinical tasks including: updating, compiling, and reporting various clinical tracking information; managing clinical studies; and any other tasks within the scope of project management.
        • As appropriate, will participate in the study development and start-up process including reviewing protocols, preparing Informed Consent Forms, developing study documents, organizing and presenting at investigator meetings, working with management on program strategy, and/or developing project-specific PM training.
        • Participate in clinical training programs and developmental programs in the field of clinical research, as needed.
        • Direct the allocation of resources to clinical projects by assigning staff to clinical studies that are appropriate to their experience and training.
        • Ensure staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
        • May participate in project management quality or process initiatives.
        • Perform other duties as requested by management
        • Work with Business Development in pursuit of their goals
        • Participate with Marketing toward corporate objectives Qualifications
          Education

          Bachelor's degree in a health-care or scientific discipline with 10 yrs of industry experience working on clinical trials and 6 years of experience in a senior leadership capacity; or equivalent combination of education, training and experience.

          Training

          The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:
          • Applicable Standard Operating Procedures
          • 21 CFR all applicable parts
          • FDA Guidance Documents including ICH E6
          • Drug Development and Approval Process
          • Medical Device Development and Approval Process Certification: None required, PM Certification or Healthcare licensures or certifications preferred

            Experience

            The ideal candidate should have:
            • Exceptional leadership skills and proven industry vision.
            • Efficient and effective time management skills with ability to successfully manage competing priorities.
            • The ability to establish and maintain effective working relationships with executive management, coworkers, managers and clients.
            • Excellent organizational and problem solving skills.
            • Advanced knowledge of, and ability to apply GCP/ICH and all applicable regulations and guidelines.
            • Superior written and verbal communication skills including excellent command of English with computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.Associated topics: administrative, administrative assistant, administrative coordinator, administrative officer, administrative staff, document, front desk, operations director, records management, support

Keywords: AdvancedRPO, Schenectady , Director, Project Management, Executive , Schenectady, New York

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