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Senior Clinical Trial Cost Expert (CTCE)

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Primary Location: Bangalore, India Full time R1244962

Job description

Job Purpose (State in one sentence the overall objective of the job)

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.

Major Activities (Describe 8-12 main activities)
1. 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
2. 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)
3. 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 close
partnership with CTT and Trial Forecast Manager partners in order to improve trial forecast
management and forecasting accuracy
4. Lead negotiations with CPOs for centralized FMVs related to IITs and local phase IV trials (not
requiring “TCFs”)
5. Lead effective engagement with Grant Plan and FMV vendor to ensure accuracy and continuous
refinement of costs at the assessment level across countries.
6. 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.
7. Integrate tollgate scenario modelling in Grant Plan and FMV cost estimations for GPT, Clinical
Team, and Trial Forecast Manager consideration.
8. Identify early productivity savings and cost avoidance (frequency of assessments, indication level
assessment, and country costs etc.). in collaboration with ‘early pricing team’
9. Develop comprehensive cost effective scenario options considering country patient allocation,
country costs and operational execution for GPT considerations.
10. 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.
11. Provide granular comparisons of Grant Plan and FMV costs estimations in consideration of
material protocol amendments.
12. 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.
13. 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 /
regions
14. 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
15. Ensure that any tools used in addition to GrantPlan for early clinical trial forecasting are
accurate and up-to-date
16. 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
17. Track that standards and metrics in pursuit of ensuring consistent implementation of Grant
Plans and FMV are developed and applied, including sharing lessons learned
18. Act as a Subject Matter Expert to support clinical trial teams with the development of GrantPlan
and FMV assessment

Job Dimensions

Financial responsibility:
(Budget, Cost, Sales, etc.)
Yes – Responsible for Grant Plans development with up to $10 to
$80 million per trial duration.
Impact on the organization: Significant contribut ion 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.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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