Job Summary:
Ideal candidate will have demonstrated success in working collaboratively with other cross functional groups to ensure the most efficient and cost effective contract solutions are achieved. The role will manage highly complex study budgets in terms of calculation of standard of care treatment issues, comparator drug and background medications, numerous specialty labs, imaging vendors and biomarkers; as well as long study durations and enrollment challenges.
Forecasting the timing of spend by expenditure type is also quite complex, requiring a highly trained individual.
Job Details:
- May serve as a resource in clinical team meetings.
- Autonomous Contracting and Financial Support responsibilities:
- Tasks are similar to Senior Clinical Contracts & Finance Associate but functions with greater independence – i.e. with little or no supervision.
- Recognized as a resource and may review work of junior CCF staff.
Is knowledgeable of Ex-US contracting requirements and proactively shares knowledge with colleagues. - Demonstrates excellence in managing multiple projects / therapeutic areas
- Demonstrates the ability to interact effectively cross-functionally
This role can manage and complete complex to non-routine clinical contracts and finance processes - Manages an operational function including supervising other staff who contribute to either clinical finance or contract production.
- May focus on both contracts and finance areas of clinical operations based on business need
- May manage CCF staff grade 27 and below.
- Manages the day-to-day activities of multiple areas in moderately complex clinical contracts and finance
- Participates in establishing departmental and cross-functional policies and procedures
- Manages contract activities for multiple clinical development programs, ensuring there is adequate staff with the skills to complete site and CRO contracts accurately, consistently and in a timely manner
- Assists other CCF staff in resolving moderately complex issues relating to contract negotiation or management
- Trains CCF staff in contract budgeting, development, and administration
- Develops spreadsheets, tracking tools and reports.
- Manages vendor relationships in conjunction with the other CCF functions, Clinical Operations,
- Bioanalytical Chemistry or Biometrics groups
Works with internal customers in vendor bidding and proposal development (RFP creation and analysis) and contract management - Assists with vendor presentation preparation and may manage Vendor bid defense meetings.
With the support of internal customers and the Legal department, manages the contract negotiation process, especially in more complex, or high value contracts
Leads contract life cycle management process as related to vendor, government, and collaborative agreements - Demonstrates excellent verbal, written, and interpersonal communication skills
This role demonstrates an in-depth knowledge of clinical research functions. - Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development (Contracts)
This role must be able to interact on high level with the clinical teams, corporate finance, corporate accounting and project management to provide oversight of clinical budgets - Demonstrates a basic understanding of the regulatory implications of contracts as related to clinical research (Finance)
Completes tasks and projects under minimal to no supervision - Demonstrates the skills of a Senior Clinical Contracts and Finance Associate
Travel may be required§
Knowledge, Experience and Skills : - 7+ years of experience with a BA in a relevant discipline, or
- 5+ years of experience with a MS/MBA in a relevant discipline
- Relevant experience typically includes contract negotiation and/or clinical finance
Strong computer skills in Microsoft products, Enterprise systems and report writing
Academic Level: Bachelors or higher
Key Financial Management Activities:
- Key Contact for Financial Planning & Analysis Group (FP&A)
Seek Monthly Confirmations from key Vendors, providing review and analysis as needed
Conduct Quarterly Vendor Reviews and Business Reviews to include review of budget spent to date, discuss any pending change orders and any billing issues - Maintain budget summary data, updates with budget v actual, expensed to date, etc.
- Manage Therapeutic Areas Latest Estimate budget in collaboration with Clinical Operations
- Gain knowledge of studies within therapeutic areas – changes, extensions, additions, etc to understand cost flux
- Work with Project Management Operations and Clinical Operations for Portfolio Planning
Development of annual budget for area working closely with Clinical Operations, Project Management Operations and Finance