Investigator Budgets Manager (Biotechnology)

SUMMARY/JOB PURPOSE:

The Investigator Budgets Manager is responsible for developing and negotiating budgets for clinical trials in accordance with protocol specifications. They conduct budget negotiations with sites, create and maintain tracking systems, and oversee Investigator Budgets (IB) Process Manager roles. Additionally, they may supervise and train staff, conduct Medicare coverage analyses, and assist in CRO relationship management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop clinical trial budgets according to protocol specifications.
• Independently manage clinical trial budget negotiations with sites, including those conducted through Contract Research Organizations (CROs) within service-level agreements.
• Maintain a tracking system of all clinical study agreements, issues, and communications with internal and external sources regarding contract and budget status.
• Responsible for directly interacting with USA and CAN sites and CROs in executing ongoing clinical trial budget negotiation reviews.
• Review and negotiate investigator-prepared budgets for FMV compliance.
• Develop management reports to support budgeting and forecasting.
• Contribute to the design, format, and content of CRO and site budget guides and template instructions.
• Prepare presentations for Investigator and vendor meetings related to budgets and site payments.
• Has internal contact with relevant departments such as Drug Safety, Clinical Operations, Legal, Medical Affairs Operations, and others as necessary.
• Participate in clinical study team meetings.
• Perform Medicare coverage analyses and may train staff or other depts.
• Coordinate CRO relationships and manage performance.
• Help foster good relationships with clinical investigators.
• Ensure compliance with Exelixis' policies and procedures.
• May hold the role of Investigator Budgets (IB) Process Manager for Investigator-Sponsored Trials (ISTs) FMV negotiations, EXEL-Sponsored Trials (ESTs) escalations and quality control (QC), Contract amendments, Data team, etc., and is responsible for the developing work instructions, internal and external training, managing workload and preparing and monitoring tracking systems. 
• With the appropriate competency and skills, may supervise staff, assign work, and perform performance appraisals.

SUPERVISORY RESPONSIBILITIES:

• May include supervisory and oversight responsibility of 1 or 2 employees.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of seven years of related experience; or,
• MS/MA degree in related discipline and a minimum of five years of related experience; or,
• PhD in related discipline and zero or more years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• Research protocol budget analyses experience
• Experience with administration of site budgets and grants, including independent preparation of clinical trial budgets and/or site payment management
• Experience with the development and negotiation of clinical trial budgets
• Strong Excel knowledge required; GrantsManager or GranPlan experience preferred
• Prior experience in Biotech/Pharmaceutical industry preferred
• Proficiency in MS Office required and Smarsheets preferred
• Oncology company experience preferred

Knowledge/Skills:

• Knowledge of advanced concepts of clinical research.
• Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
• Applies strong analytical and business communication skills.
• Proficient with broad use computer applications such as MS Office and specialized applications as needed for the job.
• Ability to deal with time demands, incomplete information or unexpected events.
• Experience in interactions with outside vendors, e.g., CROs and contract labs.
• Demonstrated ability to write and present clearly using scientific and clinical terminology.
• Advanced computer skills.
• Good organizational and planning skills.
• Strong interpersonal skills and communication skills (both written and oral).
• Ability to work effectively in a team/matrix environment.
• Ease in understanding technical, scientific, and medical information.
• Knowledge of FCPA regulations.
• Ability to problem-solve.

JOB COM