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
The Senior Clinical Project Manager of oncology cell therapy (PM) manages and oversees day-to-day responsibilities on multiple oncology clinical research trials of various phases, with expertise in Cell Therapy. The PM acts as the primary point of contact for TD2’s sponsors, vendors, third party organizations, and internal departments as delegated by the Sponsor.
Essential Functions
Project Scope
- Conduct internal and external project kick-off meetings at project start to develop and clarify the project scope and timeline and ensure clear understanding of project scope and requirements by 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 appropriate.
- Develop and inspire stakeholder relationships that result in repeat business.
Project Quality
- Ensure compliance with FDA and ICH GCP regulations, Sponsor guidelines and all internal controlled documents. Guides and mentors 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 development, implementation, and compliance of TD2 clinical policies, SOPs, working guidelines, training manuals, and informal processes.
- Leads implementation of changes to remove bottlenecks, improve processes and procedures, and improve quality, efficiency, and effectiveness of the project.
- Suggest and advocate for departmental changes to improve quality.
- Drives timely quality reviews of the Trial Master File, ensuring that appropriate documents are filed in a timely manner.
Project Risk
- Proactively work with the Sponsor, functional teams, and other stakeholders to proactively identify project risks and develop mitigation and contingency planning.
- Ensure appropriate team medical oversight of patient safety throughout the entirety of 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 Resources
- Partner with Clinical departments to ensure assigned project is 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 progress of the project to keep the team engaged and to keep the project on track with Sponsor expectations.
- Hold project team members accountable for high quality and timely deliverables.
- Ensures 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
- 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
- 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.
Perform other related duties as assigned.
Job 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.
- Minimum of 2-3 years experience working in the field of cell therapy.
- 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.
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.
- Advanced 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.
- 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).
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.
Compensation: From $130,000.00 to $150,000.00 per year
