Senior Clinical Trial Cost Expert (CTCE)
Senior Clinical Trail Cost Expert – Home Based
Clinical Trial Cost Expert is accountable for independently generating granular and accurate Grant Plan and Fair Market Value (FMV) assessments by trial, country, and other variables for all
Globally, Locally and Regionally Supported Third Party Sponsored Studies (TPSs) / Investigator Initiated Trials (IITs) and Clinical Trials (including detailed scenarios and cost-effective options),
including defined program operational considerations and potential tollgate implications in alignment with GDD portfolio strategy.
- Lead direct translation of clinical protocol visit schedule of assessment into intelligent Grant Plan and FMV cost estimations, ensuring clinical operational and scientific requirements are reflected with accuracy.
- Ensure close collaboration with clinical team for accurate “Grant Plan” specifications to improve Grant Plan estimates and reduce need for revisions
- Provide clinical operational feedback to Clinical Trial Teams on the impact of study protocol procedures, visit design and other aspects affecting the overall study forecast ( by procedure, visit, patient, country)
- Collaborate with the Global Trial Director (GTD) using clinical expertise to identify and define clinical/operational issues within the study protocol design and the overall impact of amendments and operational changes causing cost constraints and inefficiencies.
- Drive clos partnership with CTT and Trial Forecast Manager partners in order to improve trial forecast management and forecasting accuracy
- Lead negotiations with CPOs for centralized FMVs related to IITs and local phase IV trials
- Lead effective engagement with Grant Plan and FMV vendor to ensure accuracy and continuous refinement of costs at the assessment level across countries.
- Lead engagement with CPOs and regions through regular trainings and Q&A sessions to ensure mutual understanding between HQ and CPOs about Grant Plan outputs, FMV processes, country specifics /regulations and overall workload at trial sites for conducting our trials, leading to improved quality and acceptance of Grant Plan reports; build close collaboration with CPO and regional counterparts for trial budgeting.
- Integrate tollgate scenario modelling in Grant Plan and FMV cost estimations for GPT, Clinical Team, and Trial Forecast Manager consideration.
- Identify early productivity savings and cost avoidance (frequency of assessments, indication level assessment, and country costs etc.). in collaboration with ‘early pricing team’
- Develop comprehensive cost-effective scenario options considering country patient allocation, country costs and operational execution for GPT considerations.
- Identify associated potential risks and opportunities based on existing portfolio information and benchmarks to facilitate robustness and accuracy of the Grant Plan and FMV cost estimations.
- Provide granular comparisons of Grant Plan and FMV costs estimations in consideration of material protocol amendments.
- Utilize global, regional and country level cost information from data warehouses and analytical platforms to drive intelligent cost effective Grant Plan and FMV cost estimations.
- Ensure close collaboration with ‘early pricing team’ for smooth hand-over of projects (from early budget to Grant Plan) and mutual knowledge exchange about cost development in countries and regions
- Independently complete clinical and operational portions of study GrantPlan to establish FMV assessment. Initiate and lead forecast review meetings, assist with FMV specification sheet completion, distribute forecasts assessments to CPOs and request updates
- Ensure that any tools used in addition to GrantPlan for early clinical trial forecasting are accurate and up-to-date
- Drive best ratio between cost efficiency versus operational and scientific requirements, and positively influence trial complexity as it pertains to cost for increasing simplicity and value
- Track that standards and metrics in pursuit of ensuring consistent implementation of Grant Plans and FMV are developed and applied, including sharing lessons learned
- Act as a Subject Matter Expert to support clinical trial teams with the development of GrantPlan and FMV assessment
Job Dimensions & Financial responsibility:
- Responsible for Grant Plans development with up to $10 to $80 million per trial duration.
- Impact on the organization: Significant contribution to ensure Country Grant Plan and Fair
- Market Value assessment by providing cost effective, transparency and strong cost rational for trial forecasts.
- Ensure smooth interaction between Clinical, Development Operations and other stakeholders.
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