Study Grants Expert

Key Responsibilities:

• Lead direct translation of clinical protocol visit assessment schedule into intelligent Grant Plan and FMV cost estimations, ensuring clinical operational and scientific requirements are reflected with accuracy.
• Lead grant plan process: develop and lead agreement on Grant Plan/ Investigator Fees with the Study Lead, Study Start-up Lead and CPOs as needed for timely site contacting and accurate Grant Plans to improve Grant Plan estimates and reduce need for revisions.
• Collaborate with the Study Leader 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 Study Start-up team, Study Lead, Budget Manager and Early Trial Pricing partners to improve trial forecast management and forecasting accuracy.
• Provide clinical operational feedback to Clinical Trial Teams (CTTs) on the impact of study protocol procedures, visit design and other aspects affecting the overall study forecast (by procedure, visit, country). 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
• Lead engagement with CPOs and regions to ensure mutual understanding between HQ and CPOs about Grant Plan outputs, FMV processes, country specifics/ regulations and allow CPOs an early insight in overall impact on workload at trial sites for conducting trials, leading to improved quality and acceptance of Grant Plan reports and build close collaboration with CPO and regional counterparts for trial budgeting.
• Lead negotiations with CPOs for centralized FMVs related to IITs and local phase IV trials (not requiring “TCFs”)
• Lead effective engagement with Grant Plan and FMV vendor to ensure accuracy and continuous refinement of costs at the assessment level across countries.
• Identify early productivity savings and cost avoidance (frequency of assessments, indication level assessment, and country costs etc.).
• Provide granular comparisons of Grant Plan and FMV cost 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 Pricing to Grant Plan) and mutual knowledge exchange about cost development in countries / regions.
• Ensure that any tools used in addition to Grant Plan for early clinical trial forecasting are accurate and up to date.

Essential Requirements:

• Advanced degree or combination bachelor’s degree with equivalent experience
• Proficiency in English required – spoken & written, other languages is an asset.
• Demonstrated experience in drug development in Pharmaceutical Industry or with a vendor/provider from Pharma
• Excellent understanding of the clinical development process and the management of clinical trials. Strong clinical background and strong understanding of cost drivers and benchmarks for clinical trials as it relates to site contracts; ability to speak intelligently regarding cost drivers and comparative analyses.
• Strong understanding of common pricing and contracting models for clinical services.
• Demonstrated ability of completing projects on time and within budget.
• Experience in working with GrantPlan, other electronic databases, clinical and/or project management planning and reporting systems.
• Excellent knowledge of Good Clinical Practice, clinical trial set-up design and global drug development process
• Proven track record in trial operations process improvement
• Willingness and ability to champion the use of new technology

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve

India - Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.