Clinical Program Manager

5 days ago

Scottsdale, Arizona, United States TD2 Full time
Job Description

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology - it is all we do - combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking - we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.

Position Summary:

This position oversees one or more clinical trial programs from concept through closure, working with internal departments to prepare for, implement, and close out clinical trials within the program. The Program Manager triages trial and site challenges and manages customer and vendor relationships. The Program Manager may also act as a Project Manager on individual trials within the Program as needed.
Essential Functions:
  • Project Scope:
    • Provide leadership across a Sponsor's program(s) related to clinical, regulatory compliance, site monitoring, pharmacovigilance/patient safety, data management and statistical activities.
    • Participate in choosing sites for upcoming projects and tracks site engagement across the program.
    • Organize and manage meetings and discussions, both virtual and in-person, for current and future work related to the program(s).
    • Ensure meeting logistics are properly arranged.
    • Ensure key stakeholders are engaged to provide input to meeting topics and all relevant issues are included on the agenda.
    • Ensure a thorough agenda is distributed in advance of the meeting.
    • Ensure key stakeholders are in attendance for appropriate meetings.
    • Ensure meeting minutes, action items, and decisions are documented and distributed.
    • Translate vague research concepts into actionable actions for others.
    • Ensure consistency of projects within the Sponsor program (e.g., scope of work language, budgets, project plans).
    • Implement changes to remove bottlenecks, improve processes and procedures, and improve the efficiency and effectiveness of the program.
    • Suggest and propose changes for scalable growth and expansion of the program and for the clinical department.
  • Project Quality:
    • Oversee program compliance with FDA and ICH GCP regulations, Sponsor guidelines and all internal controlled documents.
    • Oversee resolution of trial non-compliances, guiding the project team(s) on corrective and preventative actions as needed.
    • Lead departmental changes to improve quality, including the development and implementation of TD2 clinical policies, SOPs, working guidelines, training manuals, and informal processes.
  • Project Risk:
    • Work with Sponsors to proactively identify program risks and develop mitigation and contingency planning, escalating issues to the appropriate parties as deemed necessary.
    • Participate in safety and efficacy data analysis across the program(s) to assist with trends analyses and data visualization.
    • Review trial-related Project Logs, reports, enrollment updates, deviation logs, and monitoring trackers for trends and preventative risk assessment.
  • Project Resources:
    • Proactively ensures assigned project is appropriately resourced and staffed for success.
    • Engages with vendors as needed to manage relationships and oversee services.
    • Keep internal project team(s) informed of program status and upcoming events to ensure engagement with Sponsor expectations.
    • Assist with protocol, informed consent form and case report form review, as appropriate.
    • Hold project team members accountable for high quality and timely deliverables.
    • Build client relationships that result in repeat business.
    • Lead or participate as an active member of cross-functional teams, working groups or as part of local or global initiatives.
    • Mentor project team(s) on identification and management of out of scope requests.
    • Serves as a back-up for Project Manager as needed for emergent situations.
  • Project Budget/Cost:
    • Work closely with Finance and BD teams to track trial deliverables, as requested, to provide trial information to ensure accurate billing.
    • Participate with Project Accountants on monthly revenue recognition, project financial reconciliation.
    • Proactively identify and manage out of scope requests. Prepare information for change orders as necessary.
  • Project Time/Schedule:
    • Manage overall timelines for projects within the program, including reconciliation of current timeline compared to the budgeted predicted timeline and percentage of work completed.
    • Schedule and lead brainstorming meetings to prevent and mitigate project timeline slippage.
  • Perform other related duties as assigned.
Job Requirements:
  • Bachelor's or Master's degree required with preference in a health or life science field. Experience may be substituted for education at TD2's discretion.
  • Minimum of 12 years of research experience.
  • Minimum of 8 years of prior Project Management experience with demonstrated leadership in a CRO, pharmaceutical, or research site environment.
  • Minimum of 8 years of early Phase 1 and/or 2 oncology experience.
  • 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 is preferred but not required.
Required 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, but not limited to, 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, vendor, and other stakeholders.
  • Superior skills in communication, judgement, problem-solving, persuading and negotiating with 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.
  • Proficiency 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).
TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran's status, gender, sexual orientation, gender identity, or gender expression.

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