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Senior Project Manager - Clinical Pharmacology Services

Company: Covance
Location: Madison
Posted on: June 15, 2019

Job Description:

Job Overview As a Senior Project Manager for our Clinical Pharmacology Services team you will oversee and manage domestic, regional and/or international clinical trials conducted at Covance Clinical research sites, external sites and data services projects. Projects generally include full service including multiple moderately complex trials managing multiple vendors and external sites for trials of high financial value, and may consist of serving in a program oversight role. Key Responsibilities:

  • The Project Manager will be the primary client contact and responsible for the facilitation of communication, managing client expectations, and building business relationships.
  • Managing scope of project and project components, budgets, timelines, and quality guidelines thereby ensuring that expectations are met while identifying and mitigating risks.
  • May be responsible for managing the project team and mentoring others in a matrix environment.
  • Contribute to strategic relationships by monitoring and reporting Key Performance Indicators (KPI), and may initiate process improvements to address variance, and may serve as a committee member on a governance structure.
  • Using thorough knowledge of clinical development, the Senior Project Manager may design delivery strategy for large scale bid defense and performs other business development activities.
  • May act as a single point of contract for the client Project Manager on a program of studies, while adhering to professional, SOP, regulatory and ICH/GCP standards.
  • Assesses resource needs for project or program delivery based on scope of services to be provided.
  • Manages and communicates scope of the program or project according to proposal, budget, timeline throughout the life cycle of the project. Works with project team on identification of work scope changes against the program or project timelines. Creates and/or review required project plans. Implement and monitor progress against project
  • Organizes, chairs, and ensures accurate documentation in meeting minutes for program or project meetings with client and team, as applicable. Completes, or delegates with oversight, the Project Log (Action/Decision/Issues) items to ensure appropriate project team member delegation and resolution.
  • Performs overall management of the program or project timelines through use of MS Project ensuring that changes or updates are made and communicated in a timely manner. Renegotiates timelines with client and project team as necessary.
  • Has extensive understanding of complex clinical, external site management, biometrics and critical path activities.
  • Supports negotiations with client to ensure budget remains within contracted terms. Improves project and program margins based on project financial expertise and minimizes write offs.
  • Proactively engages in development of project and or department quality assurance and risk mitigation activities that is cost effective and obtain agreement with client and key stakeholders
  • Collaborates with finance when project milestones or completion of contracted units of activity have been met to approve monthly invoicing, and performs client follow up as appropriate.
  • Serves as the escalation point for project uses and resolve conflicts as necessary
  • Accountable for TMFs including TMF Index & Plan, audit readiness and delivery of the TMF per agreed upon timelines, when contracted by client.
  • May oversee timely uploading of documents by the project team into the TMF for client held systems.
  • Accountable for directing the CTMS build, working with project team to ensure loading of information for site activation and timely entry of key milestones for site payment.
  • Accountable for developing Project Specific Training and ensuring project team members have read, reviewed and documented project related documents and plans.
  • Drives issue resolution at the project and program level. Ensures proper escalation of potential CQI per Covance SOPs.
  • Contributes to audit responses from agencies and clients, as appropriate.
  • Ensures lessons learned are implemented across projects currently being managed and across the department as applicable.
  • Attend Triage meeting as required
  • Increase potential for repeat business by establishing a strong working relationship with client project team striving for client satisfaction and operational excellence
  • Contributes to proposal strategy, development, and lead bid defense strategy for assigned business development opportunities.
  • May own a relationship with key strategic clients(s) with development and implementation of partnership plans, processes, tool and templates
  • Leads implementation of process excellence initiatives on projects and across department that enhance the efficiency and the quality of the work performed on a program or project.
  • Develop strategic client metrics and track project metrics across program as needed. Monitor and report KPI for strategic relationships, actively managing to ensure they are within the scope of the contract and initiate process improvements to address variance
  • May serve as a committee member in a governance structure for strategic clients (use for leveling
  • Assists training and development of more junior and project team staff.
  • Develops or is a SME contributor to department training material
  • Perform other duties as assigned by management. Site Management
    • Responsible for the oversight of site start up activities.
    • Oversees the coordination of the study activation components of the project from an oversight level including Feasibility, Site selection, Activation, Site Contracting, Label/Supply, Regulatory Submission, Greenlight.
    • Assists in the design and maintenance of tools/ processes relevant to feasibility assessments and patient recruitment campaigns.
    • Supervision of Investigator package review and approval prior to drug shipment.
    • Supervision of study set-up with the clients regarding pre-study documentation for Investigator packages.
    • Supervision of Site Budget and Statements of Agreement (SoA) documents that leads to an executed site contract
    • Supervision of Document Review, including Informed Consent Forms, Advertisements, labels and protocols. Education/Qualifications Education:
      • University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
        • In lieu of the above requirement, candidates with a two (2) year Associate Degree and additional five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered. Preferred:
          • Certified in Clinical Research - PMP, SOCRA/ACRP Certification
          • Masters or other advanced degree
          • PMP Certification
          • Six Sigma trained Experience Minimum Work Experience:
            • Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company/CRO including demonstrated skills and competency in project management tasks.
              • Acceptable: In lieu of above experience requirement, a combination of other experiences including, but not limited to preclinical research, clinical biometrics, clinical study management, clinical monitoring, and clinical project management may be considered.
                • Experience in managing projects in a virtual environment.
                • Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
                • Financial awareness and ability to track project progress against financial milestones.
                • Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
                • Demonstrated ability to lead by example and to encourage team members to seek solutions.
                • Excellent communication, planning and organizational skills.
                • Ability to work independently.
                • Ability to negotiate and liaise with clients in a professional manner.
                • Ability to present to staff at all levels.
                • Good computer skills with good working knowledge of a range of software packages.
                • Detailed knowledge of project management processes. Preferred:
                  • Working knowledge of Covance with cross functional department expertise.
                  • Basic knowledge of Covance sales and business development strategies and procedures.Working knowledge of Covance SOPs

Keywords: Covance, Madison , Senior Project Manager - Clinical Pharmacology Services, Healthcare , Madison, Wisconsin

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