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Clinical Contracts Associate - III
Ref No.: 18-15166
Location: Foster City, California
Clinical Contracts Associate III
Duration - 6 months
Location - Foster City


Associate Manager, Financial Management of HIV Therapeutic Area, CCF

Specific Responsibilities and Skills for Position:
• Key Contact for Financial Planning & Analysis Group (FP&A), Clinical Operations Study Teams, Project Management Operations, and Accounting.

• Manages monthly accruals from key Vendors, providing review and analysis as needed

• Conducts Quarterly Financial Reviews with Vendors which includes review of budget spent to date, discussion of pending change orders and billing issues

• Maintains budget summary data and provides updates and commentary for budget v actuals, expensed to date, etc.

• Manages Therapeutic Area Latest Estimate budget and development of ad-hoc budget estimates working closely with Clinical Operations, Project Management Operations, and FP&A

• Gains knowledge of studies within therapeutic area – changes, extensions, additions, etc. to understand cost flux and cost drivers

• Works with Project Management Operations and Clinical Operations for Portfolio Planning

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 comparator drug and background medications, numerous specialty labs, imaging vendors and biomarkers; as well as long study durations and open label extensions. Forecasting the timing of spend by expenditure type is also quite complex, requiring a highly trained individual.

Essential Duties and Job Functions:
 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.

 May serve as a resource in clinical team meetings.

 Manages the day-to-day financial management activities for multiple clinical development programs, ensuring there is adequate staff with the skills to complete tasks and projects accurately, consistently and in a timely manner.

 Demonstrates the skills of a Senior Clinical Contracts and Finance Associate but functions with greater independence – i.e. completes tasks and projects under minimal to no supervision.

 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.

 Recognized as a resource and may review work of junior CCF staff.
 Participates in establishing departmental and cross-functional policies and procedures.

 Is knowledgeable of contracting requirements and proactively shares knowledge with colleagues.

 Assists other CCF staff in resolving moderately complex issues relating to contract negotiation or financial 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

 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.

 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).

 Demonstrates a basic understanding of the regulatory implications of contracts as related to clinical research (Finance).


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