New London, CT - Clinical Project Manager

Job Description:

• Lead Operational Delivery at the Study Level
• Accountable for the coordination of planning, initiation, completion and reporting of clinical research studies within or across programs from study concept to reporting, submission and as needed regulatory defense activities within a program
• Team Leadership
• Establish and charter the team through interaction with Dev Ops and partner lines
• Ensure appropriate team alignment across lines and divisions and appropriate team structure for optimized operational conduct
• Lead study team and drive to align functions, roles and vendors to deliver high quality, cost targeted and timely execution of clinical research study deliverables in compliance with the Clinical Development Plan and relevant regulatory requirements
• Develop and maintain positive team dynamics
• Provide facilitation and effective decision making
• Represent CCS at governance boards and review committees as needed
• Lead the development, endorsement and maintenance of study level plans
• Partner with the Project Planner to ensure that schedule, cost, resource management, study quality are established and maintained between clinical study activities and the overall development schedule
• Ensure execution against the study plan
• Manage delivery of study team data/work products according to the plan
• Manage critical changes and/or variance in:
• financial forecast and schedule
• scope and deliverables
• Lead the team in managing issues and problem solving
• Provide “Operational Review” updates/presentations to senior leadership as requested
• Demonstrate Pfizer Core Competencies in motivating and supporting the study team
• Influence Strategy and Ensure Operational Alignment
• Contribute to the clinical study components of the Clinical Development Plan (including protocol design) with respect to time, operational feasibility, country allocation, and study-level resources required to deliver individual studies against the plan
• Lead or contribute to Development of Strategic Clinical Operations Plan (SCOP)
• Translate development plan goals into tangible relevant goals for studies within the program.
• Assess impact of technologies required to deliver the clinical plan and incorporate the development of these technologies into the clinical program to ensure conduct and data collection suitable for purpose
• Provide project management support for biomarker and enabler studies within the RU/BU
• Provide project management support to facilitate Candidate Selection to FIH activities
• Partner with RU/BU leadership to provide project schedule and budget information to enable portfolio management
• Partner with project planner and study team members to develop study level plans and goals and ensure alignment with overall development plan.
• Propose alternative study operation strategies to optimize use of time cost and resource
• Maintain and enhance knowledge in disease and technical areas and in global regulations/guidelines pertaining to clinical trials
• Optimize Operational Control and Effectiveness
• Manage Study Resources
• Establish accurate study level $/FTE baseline and forecasts
• Manage, update and deliver against forecast
• Ensure Operational Effectiveness
• Identify team performance issues and partner with leadership to develop appropriate action plans
• Ensure effectiveness and team health
• Address system or process issues hindering delivery
• Lead implementation of process design to increase productivity
• Ensure Program Alignment – through close liaison with the GL and RU/BU project manager (e.g., RPM)
• Apply effective project management skills to optimize operational conduct including problem identification, mitigation planning and driving resolution to ensure the studies deliver in accordance with overall project/program goals
• Support program-wide implementation of technology-enabled processes in close partnership with appropriate RU/BU, platform and enabling groups.
• Analyze and Manage Risks & Opportunities
• Lead the Study Team in:
• Inspection Readiness preparation and coordination
• Identify and communicate opportunities and risks to the RU/BU project leadership for integration in Risk Management Plans
• Prepare, maintain and implement action plans
• Mitigation and contingency plans
• Ensure cross-functional and internal CCS awareness and buy-in to the risk/opportunities action plans
• Ensure communication and integration of study level risks/opportunities at the program level through close liaison with GL and project manager (e.g., RPM)
• Manage Information & Communications
• Provide high quality study information to support decision making
• Ensure effective communication across study teams, removing barriers when necessary
• Ensure study team and stakeholders and informed of progress against goals, major study risks/opportunities and corresponding contingency/mitigation plans
• Ensure issue escalation and appropriate resolution

REQUIREMENTS:

• Minimum of BS/BA in a biomedical discipline or equivalent education/training is required
• Previous experience in clinical research and development and knowledge of Good Clinical Practice (GCP)
• Effective verbal and written communication skills are required to enable building of customer relationships both inside and outside the organization
• Advanced education/training in a biomedical discipline and clinical trial management
• Substantial clinical operations and pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues
• Leadership, project management, resource management, administrative and technical capabilities
• Matrix/Team leadership skills
• Experience supporting regulatory submissions highly desired

SUBMIT RESUME to Resume@ABOUT-Consulting.com
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