- Ensure compliance with FDA and ICH GCP regulations, Sponsor guidelines and all internal controlled documents.
- Provide leadership to project related clinical, regulatory, site monitoring, safety, data management and statistical activities.
- Track and assist with resolution of trial non-compliances, working on corrective and preventative actions as needed.
- 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.
- Conduct internal and external project kick-off meetings at project start to develop and clarify the project scope and timeline and ensure clear
- understanding by all project team members.
- 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.
- Prepare and review trial-related reports, including enrollment updates, deviation logs, monitoring trackers, etc.
- Work with the Sponsor to proactively identify project risks and develop mitigation and contingency planning.
- Create detailed project plans for each element of the project.
- Prepare 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.
- Assist with protocol, informed consent form and case report form development, as appropriate.
- Implement changes to remove bottlenecks, improve processes and procedures, and improve the efficiency and effectiveness of the project.
- 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.
- Ensure that project and site budgets accurately reflect project costs and proactively communicate discrepancies to the team members responsible for coordinating the pricing and scheduling of the project.
- Review and maintain project related documentation including budgets, client specific requests, action items, and deviations.
- Ensure adherence to all contracts associated with the project. Identify and manage out of scope requests. Prepare information for work scopes changes when necessary.
- Track monthly financial data associated with each project and work closely with the finance department to ensure accurate billing.
- Ensure the project is appropriately resourced and staffed for success.
- Coach team members as necessary to ensure successful project deliverables.
- Ensure required training is completed by project staff prior to their participation on the project.
- Suggest and push for departmental changes to improve quality.
- Assist with the development and implementation of TD2 clinical policies, SOPs, working guidelines, training manuals, and informal processes.
- Perform other related duties as assigned.
- Bachelor’s or Master’s degree with preference in a health or life science field.
- Oncology nursing education is preferred. Minimum of 8 years’ experience in research.
- Minimum of 3 years’ prior Project Management experience with demonstrated leadership in a CRO, pharmaceutical, or research site environment.
- Minimum of 3 years’ early Phase 1 and/or 2 oncology experience. Experience in other complex therapeutic areas, such as rare and orphan diseases, cardiac or AME trials may be substituted at TD2’s discretion.
- Evidence of a strong understanding of all aspects of clinical trials.
Required Specialized/Technical Skills
- Expert knowledge in clinical oncology drug development.
- Thorough understanding of CRA activities and responsibilities.
- 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 third-parties.
- High-level skills in communication, judgement, problem-solving, persuading and negotiating.
- Advanced working knowledge of MS Office products including Word, Excel, and PowerPoint.
- Preferred skills in MS Project. Proficiency using required electronic systems (e.g., CTMS, eTMF, EDC) Ability to work under tight deadlines.
- Ability to travel approximately 15% (dependent on Sponsor/trial requirements).
- Project Management Professional (PMP) Certification is preferred but not required.
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