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Senior Clinical Project Manager

2 months ago

Scottsdale, Arizona, United States TD2 Full time
Job Summary

We are seeking a highly experienced Senior Clinical Project Manager to join our team at TD2, a leading Contract Research Organization (CRO) specializing in oncology drug development. As a key member of our project management team, you will be responsible for overseeing the day-to-day activities of multiple clinical research trials across various phases.

Key Responsibilities
  • Project Scope Management
    • Conduct thorough project kick-off meetings to develop and clarify project scope and timeline, ensuring clear understanding among all project team members.
    • Provide leadership to project-related clinical, regulatory, site monitoring, safety, data management, statistical activities, and other affected functional teams.
    • Drive protocol, informed consent form, and case report form development at the trial level, as necessary.
  • Project Quality Assurance
    • Ensure compliance with FDA and ICH GCP regulations, Sponsor guidelines, and all internal controlled documents. Guide and mentor others in this area.
    • Drive the tracking and analysis of trial non-compliance instances, leading appropriate internal teams and the Sponsor in corrective and preventative actions as needed.
    • Ensure required training is completed by project staff prior to their participation in the project.
    • Review and maintain project-related documentation, including client-specific requests, action items, and deviations.
    • Lead the development, implementation, and compliance of TD2 clinical policies, SOPs, working guidelines, training manuals, and informal processes.
    • Lead the implementation of changes to remove bottlenecks, improve processes and procedures, and enhance quality, efficiency, and effectiveness of the project.
    • Suggest and advocate for departmental changes to improve quality.
    • Drive timely quality reviews of the Trial Master File, ensuring that appropriate documents are filed in a timely manner.
  • Project Risk Management
    • Proactively work with the Sponsor, functional teams, and other stakeholders to identify project risks and develop mitigation and contingency planning.
    • Ensure appropriate team medical oversight of patient safety throughout the project. Bring safety concerns to the immediate attention of the project medical team.
    • Prepare and review trial-related reports (e.g., enrollment updates, deviation logs, monitoring trackers, Key Performance Indicators), anticipating the need for unique reports based on trial factors.
  • Project Resource Management
    • Partner with Clinical departments to ensure assigned projects are appropriately resourced and staffed for success.
    • Participate in vendor discussions to manage relationships and oversee services.
    • Lead regular status meetings and ensure accurate meeting minutes are distributed throughout the project to keep the team engaged and on track with Sponsor expectations.
    • Hold project team members accountable for high-quality and timely deliverables.
    • Ensure strong stakeholder relationships that result in repeat business.
    • Lead and participate as a member of cross-functional teams, working groups, or as part of local or global initiatives.
    • Drive the creation of detailed project plans for each element of the project.
    • Train, mentor, and coach team members as necessary to ensure successful project deliverables.
  • Project Budget/Cost Management
    • Ensure that project and site budgets accurately reflect project costs and proactively communicate discrepancies to team members responsible for coordinating the pricing and scheduling of the project.
    • Ensure adherence to all contracts and SOWs associated with the project.
    • Proactively identify and manage out-of-scope requests. Ensure all departments prepare information for change orders as necessary.
    • Manage project and site budgets to ensure that project costs are accurately reflected, and discrepancies are proactively communicated to the team members responsible for coordinating the pricing and scheduling of the project.
    • Track monthly financial data associated with each project and work closely with the finance department to ensure accurate billing.
  • Project Time/Schedule Management
    • Prepare and maintain a detailed project timeline. Monitor and coordinate the efforts of the entire project team to ensure key milestones are met on time.
    • Hold brainstorming meetings to prevent and mitigate timeline slippage.
Requirements
  • Bachelor's or master's degree with preference in a health or life science field. Experience may be substituted for education at TD2's discretion.
  • Minimum of 10 years of experience in research.
  • Minimum of 6 years of prior Project Management experience with demonstrated leadership in a CRO or pharmaceutical environment.
  • Minimum of 5 years of early Phase 1 and/or 2 oncology experience.
  • Global clinical project management is required.
  • Experience in other complex therapeutic areas, such as rare and orphan diseases, cardiac or AME trials, as well as TD2 performance and work experience, may be substituted at TD2's discretion.
  • Project Management Professional (PMP) or other Project Management Certification preferred.
Specialized/Technical Skills
  • Expert knowledge of the clinical oncology drug development process.
  • Expert understanding of the role and responsibilities of Project and Program Managers, including management of the project scope, quality, risk evaluation/mitigation, resource management, budget/costs, and timeline.
  • Expert understanding of Clinical Monitoring, Data Management, Biostatistics and Programming, Medical Monitoring, Safety Management aspects of clinical research trials.
  • Strong organization and multi-tasking skills in a fast-paced environment.
  • Ability to work collaboratively with team members and build excellent relationships with Sponsors, sites, vendors, and other stakeholders.
  • Advanced skills in communication, judgment, problem-solving, persuading, and negotiating with the ability to diffuse difficult situations and bring calmness and balance to the project.
  • Able to independently take initiative and work with vague instructions.
  • Strong business acumen.
  • Advanced skills in MS Office products, including Word, Excel, Outlook, SharePoint, and PowerPoint.
  • Advanced skills using required electronic project management and clinical trial management systems (e.g., CTMS, eTMF, EDC).
  • Ability to travel approximately 15% (dependent on Sponsor/trial requirements).