Contract Senior Manager, Clinical Site Budgets and Outsourcing

TalentBurst•South San Francisco, CA

3d•Hybrid

About The Position

Client is a clinical-stage biotechnology company developing next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. Our proprietary T-cell reprogramming technologies are designed to overcome the biological barriers that limit durable clinical response with current cell therapies. We are united by a shared purpose: to give people with cancer, and the people who love them, the gift of time. Our culture is grounded in Science, driven by Courage, and built on Respect and Collaboration. Client is headquartered in South San Francisco, California, with additional sites in Seattle and Bothell, Washington. Client is seeking a Contract Senior Manager, Clinical Site Budgets and Outsourcing to support our Clinical Development organization at a pivotal point in the company's growth. This role owns the outsourcing lifecycle for assigned US and ex-US clinical programs under Client's Clinical Development portfolio – vendor selection, financial due diligence, contract and change order negotiations, ongoing vendor performance, and spend management – in support of Clinical Development, Drug Safety, and Regulatory. It is also the primary owner of clinical trial site budgets across assigned studies, including review and negotiation. Partnering closely with Clinical Operations, Finance, Legal, and CRO partners, the successful candidate will ensure outsourced activities and site budgets are executed on time, within budget, and in compliance with company policy and applicable regulations (e.g., GCP). The position is responsible for ensuring a high level of fiscal discipline with a focus on fair market value (FMV) benchmarking and budget-to-actual tracking across assigned studies.

Requirements

Demonstrates communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
Strong strategic thinking and project management skills; documentation and administration maintenance
Exercises sound judgment and makes decisions appropriate for the organization; escalates early and with recommendations
Results-driven; takes initiative and ownership to accomplish work; influences collaboratively to move cross functional and external partners to timely decisions
Demonstrates flexibility and embraces change in a dynamic, rapidly growing environment
Strives for continuous improvement and embraces innovative ideas in daily work
Strong financial and analytical acumen; able to build, interpret, and manage complex site and vendor budgets with appropriate and supported assumptions
Proficient with budgeting and financial tracking tools (e.g., Excel, Smartsheet)

Responsibilities

Lead the identification and selection of Clinical Development vendors, including Contract Research Organizations (CROs), central labs, imaging vendors, and other specialty service providers
Manage the documents and processes needed to select the optimal contract service provider (CSP), including RFI/RFP development, bid grid analysis, and final recommendation for stakeholders
Negotiate contract business terms, scopes of work, master service agreements, pricing, and payment schedules within approved parameters; manage the routing of contractual documents to ensure timely and compliant execution
Assist Clinical Development teams in defining, reviewing, validating, and negotiating vendor change orders and amendments for acceptance and execution; collaborate with Finance and Legal to provide line of sight to incremental costs for corporate planning or highlight any contractual issues
Monitor vendor performance against contractual KPIs/SLAs and help ensure vendors/partners are delivering in line with expectations and contracts; maintain vendor oversight documentation to support oversight expectations and inspection readiness
Participate in and help manage vendor governance meetings and day-to-day vendor relationships
Support Finance/Accounting with general contracting queries, payment schedule interpretation and overall contract burn management
Build and/or validate per-patient and per-site budget models based on protocol-required procedures, standard-of-care carve-outs, and visit schedules using FMV (fair market value) industry benchmarking data and internal precedent
Own the review, negotiation, escalation and maintenance of clinical trial site budgets and investigator grants across assigned studies
Partner with Clinical Operations to facilitate interactions with CROs and clinical sites
Interpret and apply Medicare Coverage Analysis determinations, including routine vs. non-routine care classification, validate budget assumptions, resolve site billing questions, and support negotiation positions
Track site-level spend against forecast, identify variances, and drive timely reforecasting
Maintain and continuously improve budget templates, tools, trackers and standardized cost assumptions database used across studies
Partner with Finance/Accounting to support accurate trial accrual estimates and monthly close processes