Independently manage complex and/or priority programs or contracting situations with minimal supervision. Function as expert resource for Clinical trial budget subjects.
1. Manage budgetary requirements of clinical program, by providing consolidated latest estimates on current year budget and future year planning budget. Identify issues and propose mitigating plans for facilitating decision making. Identify productivity savings.
2.Develop and agree on the trial budget with the clinical trial teams and assist with securing approvals. Initiate and lead resource review meetings. Challenge and track program/trial timelines, resource requirements and expenditures and initiate adjustments as needed. Liaise with the GPTD/ GBMD and other global line functions to assist clinical teams with securing sufficient resources.
3.Ensure clinical trial planning and budgeting systems are accurate regarding timelines, forecasts, expenditures and internal resource planning. Liaison to global departments regarding forecasts and status of program timelines and resources.
4.Track that program specific standards and metrics are developed and applied. Ensure processes are implemented consistently across the program(s).
5.Active member of International Clinical Team (ICT). Core member of CTT and PFT
6.Provide clinical trial process and budget training to clinical staff.
7.Conduct training sessions and mentor new CTBMs to support clinical trial teams with the development of trial budget and operational strategy, and assist with securing approvals.
8.Faculty member for OGD&GMA and OTM training programs, author or reviewer for clinical SOPs.
9.Provide input to the development of process standards/tools and performance metrics to achieve excellence in OGD & GMA and OTM. Drive implementation to achieve results faster, economically and more effectively in cooperation with key stakeholders.
10.Develop best practices for allocating and managing resources. Participate in cross-functional process improvement initiatives.
11.Manage TCF/Study CPO costs and alignment with TTG
a. Manage Grant Plan Process: request and lead meeting, distribute estimates
to CPO, request updates.
b. Manage country study-related fixed and variable lifetime costs and ensure
adherence to approved TTG.
c. TCF management- ensure TCF cost estimates are accurate and updated as
necessary. Release and approve TCF as per guidance.
d. Evaluate total actual vs. projected spend for total lifetime cost.
e. Manage yearly CPO forecast and actuals
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Will be hired at level commensurate with experience
Bachelor degree in a Life Science OR a Bachelor degree in Business.
Advanced degree (MS, PhD, MBA) is preferred.
Fluent English (oral and written)
1. At least 5 to 7 years of related experience in Drug Development in Pharmaceutical Industry or with a vendor/provider from Pharma
2. Excellent understanding of the clinical development process and the management of clinical trials.
3. Strong knowledge of the CRO/Central Labs/Specialty Provider and investigator fees cost drivers.
4. Superior understanding of common pricing and contracting models for clinical services.
5. Strong clinical background and strong budgeting understanding (understanding of cost drivers and benchmarks for clinical trials) as it relates to contracts and cost reductions; ability to speak intelligently regarding cost drivers and comparative analyses.
6. Demonstrated ability of completing projects on time and within budget.
7. Experience in working with electronic databases, clinical and/or project management planning and reporting systems.
8. Excellent written and oral communications skills.
9.Excellent influencing and negotiating skills.
10. Superior problem solving skills.
11. Demonstrated willingness to make decisions and to take responsibility for such.
12. Excellent interpersonal skills (team player)