The TAPM provides project management leadership for the cross-functional CDRA teams (eg: PVRM, Regulatory, Medical Monitoring, Clinical, and Program Finance, Clinical Operations, etc.). Manages therapeutic areas clinical projects by overseeing the initiating, planning, execution, and closeout of the clinical development plans for clinical programs. Facilitates strategic planning for operational plans with CDRA and external partners as appropriate.
Works closely with the Therapeutic Area Head (TAH), Development Program Operations (DPO), TA Operations Lead, Clinical Trial Management (CTM) Operations Lead, and Program Direction to ensure clinical study deliverables support clinical program goals and project execution
Works closely with the TAH, DPO and CTM Operations Lead to ensure the required deliverables are aligned with meeting the review committee objectives
Facilitate quarterly and annual resource forecasting across all CDRA functional areas
Leads timeline and cost estimates developed for clinical program lifecycle management
Assess and monitor the variance from plan across CDRA functional areas to determine any impact on the clinical development plan (CDP)
Drive Clinical Study Concept (CSC) completion
Works with Clinical Finance, Medical Director, CTM Operations to create an estimate for CSCs as well as Blue Sheet Budgets (BSB) from Protocols
Work with Medical Director and CTM Operations to create a timeline estimate for CSCs as well as vetted timelines at the time of CSC approval
Responsible for analysis of Key Performance Indicators (KPI) and developing appropriate action plans
Coordinate risk analysis and contingency planning for clinical programs
Facilitates Clinical Development Sub-Team (CDST) comprised of cross-functional team representatives from CDRA, including but not limited to Clinical Sciences (early and late phase), Medical Writing, Clinical Trial Management, Biostatistics, Data Management, and Regulatory Affairs
Serves as an escalation point for CDST members and coordinates and leads the cross-functional resolution regarding issues potentially impacting clinical program objectives and deliverables, timelines, budgets and quality
Provides clinical program updates to management on an as-needed basis
Serves as clinical project management liaison on collaboration teams with external partners
Manages the development and adherence to key regulatory submission timelines and communication plans for global submissions
Responsible for overall project timeline close-out
Lead and participate in the debrief and lessons learned exercises
Initiates and participates in strategic initiatives within the CDRA organization
Contributes to the creating and revision of functional Standard Operating Procedures (SOPs) and Guideline documents
• 10 years relevant FDA regulated industry experience preferably with drug development; at least ten of which are in project management
• Project Management Professional (PMP)® - preferred
• NIH certification on the Protection of Human Research Subjects - preferred
Our Client EBP is the most versatile family-owned distribution partner that provides a broad range of essential supplies & services for progressive commercial organizations throughout the eastern and domestic United States.
Since 1918, our Client has strengthened your ability to go forward – by making your supplies work harder and helping you work smarter.
As they head into a second century of business, the expert thinking, top brands, service and training you depend on are being expanded. A new Training Academy, an expanded ecommerce experience and new innovations from partners in the industry.