Associate Project Manager
- 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 with assistance in areas of less familiarity.
- Track and assist with resolution of trial non-compliances, with guidance 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 and department leadership for assistance in decision making.
- Conduct internal and external project kick-off meetings with assistance 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.
- May mentor with a more senior Project Manager or department leadership for assistance in identifying trial risks.
- Create detailed project plans for each element of the project with assistance of a Project Manager or department leadership.
- 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.
- Suggest changes to remove bottlenecks, improve processes and procedures, and improve the efficiency and effectiveness of the project.
- Mentor with a more senior Project Manager on assigned studies.
- Hold project team members accountable for high quality and timely deliverables.
- Build client relationships that result in repeat business.
- Participate as a member of cross-functional teams, working groups or as part of local or global initiatives.
- Review project and site budgets and work with department management 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.
- 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 discuss out of scope requests with department management.
- With guidance, 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.
- Work with department management to 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 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 degree with preference in a health or life science field Minimum of 5 years’ experience in research.
- Minimum of 2 years’ experience working on early Phase 1 and/or 2 oncology trials.
- Experience in other complex therapeutic areas, such as rare and orphan diseases, cardiac pr AME trials may be substituted at TD2’s discretion.
- Evidence of understanding aspects of clinical trials.
Required Specialized/Technical Skills
- Knowledge of the clinical oncology drug development process.
- Understanding of CRA activities and responsibilities.
- Good 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.
- Experience 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).
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