5 years of Clinical Trial / Project Management in Drug Development
4+ CRO or Vendor oversight for Global Studies
Experience managing clinical Study Budgets and essential regulatory documents (CRFs, TMF, IRB documents)
4 Year degree required (MS Preferred)
SUMMARY: The TEMP Therapeutic Area Project Manager provides project management leadership for the cross functional clinical development teams, ensuring deliverables are met on time, within budget and in accordance with quality expectations. For the assigned therapeutic area(s), they support the planning of the clinical strategy, develop and monitor the clinical program budget and timelines against the baseline. Facilitates strategic planning and decision-making, drive activities to completion, troubleshoots issues, and identifies/manages risks within the clinical program and with external partners, as appropriate.
* Teams: Guides and facilitates the clinical development team to plan and execute the clinical program's goals for the assigned assets within a therapeutic areas. Coordinates and drives the clinical strategy to completion across the various development phases (e.g. pre-IND to life cycle management) within scope, timelines and budget.
* Communication and Collaboration: Manages the clinical program interactions to ensure that the cross-functional teams are aligned on the deliverables and successfully set up to execute. Fosters a productive and positive team environment and collaborates closely with the development program manager, operations lead and clinical development lead. Liaises between the strategic development team and the clinical development team to communicate relevant and contemporaneous inputs/outputs from each team. Effectively facilitates the clinical development team meetings and translates the strategic clinical goals into operational plans. For collaborator programs, will act as the conduit to provide status reports on internal clinical and operational activities.
* Planning: Drives the discussions related to early planning to develop the studies that will form the clinical development plan and integrated clinical timelines. Facilitates the protocol expanded synopsis process from collection of early assumptions to document finalization with associated budget and timelines. Collaborates with clinical logistics to provide assumptions for early drug supply planning. Plan and monitor the clinical deliverables required for regulatory submissions (e.g. IND, CTA, BLA, MAA, etc.)
* Project Reporting and Tracking: Maintains knowledge of key clinical data and milestones for assigned projects and serves as the primary contact for information and updates. Provides project summaries and general guidelines to support presentations to senior management and collaborators as needed.
* Budgets and Timelines: Participates in scenario planning to provide management with decision-making information, such as high-level timelines and costs. Coordinates with the cross-functional team and gains alignment on the assumptions that will drive the initial budget and timelines. Accountable for the budget development process and facilitates the budget approval process with the clinical study team. Participates in the quarterly reforecast cycle to ensure the clinical assumptions are current and accurate within the operational development plan documents. Oversees clinical study timelines and performs ongoing assessment of current timelines against the baseline.
* Process Improvement: May participate in workstreams, initiatives and review functional Standard Operating Procedures (SOPs) within the Global Development organization
* Problem Solving and Risk Identification: Identifies risks and develops/manages mitigation strategies. Facilitates action follow-up and issue resolution within the matrix-environment of the clinical development team in order to deliver against project goals. Leads and participates in Lessons Learned debriefs.
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