Senior Clinical Site Budget Specialist

ImmunityBio, Inc.San Diego, CA
$136,500 - $150,000Onsite

About The Position

The Senior Clinical Trial Budget Specialist position will develop, deploy and administer standardized approaches to suppliers, contracts, and budgets for clinical trial operations. The role will build clinical trial budgets for negotiation as well as provide budget and administrative policy guidance to the clinical operations departments. The senior Clinical Trial Budget Specialist may mentor, coach and train lesser experienced budget team members.

Requirements

  • Bachelor’s degree with 7+ years’ progressive experience in budget and contract development required
  • 4+ years’ experience in clinical research required
  • Knowledge and expertise in the use of Clinical Trial Management Systems and excel for budget development and negotiation
  • Advanced skills in Excel
  • Knowledge in coverage analysis and CPT coding
  • Sound judgment, problem solving, matrix management, and collaboration in selecting methods and techniques for obtaining solutions to problems.
  • Knowledge of the drug development process and cross-functional responsibilities
  • Ability to influence various teams without direct reporting structure
  • Extremely flexible, highly organized, and able to balance and quickly shift priorities
  • Excellent project and process management skills with a track record of accomplishing tasks and delivering results
  • Excellent interpersonal and communication skills, strong customer-service orientation, and the ability to work effectively with all levels of the organization and with a wide range of clients, individually and in groups
  • Ambitious and driven with a keen interest in improving processes and development, both as a team and personally
  • Understands supplier management and billing/regulatory compliance guidelines.
  • Proven ability to handle extremely confidential information

Nice To Haves

  • Experience with contract negotiations preferred
  • Experience with domestic and international research studies preferred
  • Experience using Veeva CTMS and payments

Responsibilities

  • Guide and support clinical operations departments in the site budgeting process for ImmunityBio trials, as well as investigator initiated trials including the preparation, negotiation and execution of clinical trial budgets, service contracts and agreements
  • Identify opportunities for improvement to the clinical trial business process and recommend and draft Standard Operating Procedures (SOPs) and templates
  • Monitor budget timelines, provide regular updates to trial stakeholders, and recommend tactics to achieve clinical program milestones
  • Provide reports/analysis of trends in negotiation of budgets/agreements to management
  • Triage incoming protocols for coverage analysis and budget build
  • Perform detailed coverage analysis for clinical trials based on Center for Medicare and Medicaid Services (CMS) Policy, National Coverage Determinations (NCDs), Local Coverage Determination (LCDs), Drug Compendia, etc.
  • Develop, review, and negotiate clinical trial budgets
  • Partner and communicate with Legal, Finance/Accounting, and Clinical Operations Teams.
  • Develop and maintain study-specific site budget templates and negotiate parameters for the budgets and contracts.
  • Assist in budget, forecasting, auditing, and variance management activities
  • Respond to coverage analysis, billing compliance, and budget-related questions
  • Act as subject matter expert to select the best method to address billing compliance issues and negotiate budgets
  • Educate others on the processes for budgets and billing compliance as needed
  • Provide mentoring, coaching, and training to lesser-experienced members of the budget team
  • Performs ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities.

Benefits

  • Medical, Dental and Vision Plan Options
  • Health and Financial Wellness Programs
  • Employer Assistance Program (EAP)
  • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
  • Healthcare and Dependent Care Flexible Spending Accounts
  • 401(k) Retirement Plan with Company Match
  • 529 Education Savings Program
  • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
  • Paid Time Off (PTO) includes: 11 Holidays
  • Exempt Employees are eligible for Unlimited PTO
  • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
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