Clinical Trial Budget and Contracts Manager

POSITION SUMMARY:

Job Function: Clinical Operations

Title: Budgets & Contracts Manager

As a member of the Clinical Operations team, the Budgets & Contracts Manager is responsible for managing clinical agreements, budgets, payment follow-up, and corresponding processes in support of the department. This individual should have experience in managing all aspects of study contracts and payments and is expected to provide functional expertise to ensure that timelines, costs, and quality metrics are met and that the study contract is managed in compliance with the study protocol.

The Budgets & Contracts Manager works closely with study teams, clinical site personnel, and other stakeholders to finalize budgets, execute contracts, and ensure payment reconciliation. They also partner with legal, accounts payable, procurement, and finance to lead and influence improvement initiatives that ensure the integrity of cross-functional budgets, contracts, and payment processes. This role reports into the Associate Director of Clinical Trial Business Operations 

All clinical agreement work will be done in accordance with company policies, Standard Operating Procedures (SOPs), legal and regulatory requirements, and using fair market valuation.

PRIMARY RESPONSIBILITIES:

• Responsible for the day-to-day management of site contracts and tracking to OKRs for key deliverables.

• Lead meetings with study teams and data management, to ensure creation of site budget templates and study plan templates are aligned to study protocols and their database.

• Lead site contract negotiations, communicate risks to cross functional partners with proposed solutions.

• Deliver activity status updates to internal and external parties, communicate timeline risks and propose mitigations.

• Collaborate with cross functional partners to lead systems updates, so that they meet team requirements and are optimized for day‐to‐day management of assigned tasks.

• Manage and track clinical contracts, study plans, amendments, site budgets, and POs across multiple studies, and multiple systems, simultaneously.

• Utilize existing processes to draft, negotiate and execute a variety of clinical agreements in collaboration with Legal and Clinical Operations Study teams.

• Propose and implement solutions for identified gaps in budget, contract, and payment processes.

• Analyze Fair Market Value (FMV) to support budget development, negotiation, and documentation.

• Issue purchase requests against executed contracts and manage the lifecycle of corresponding POs; tracking associated invoices and their payments.

• Ensure timely payments to sites, partnering closely with AP to troubleshoot as needed.

• Ensure that budgets, contracts, PRs/POs are loaded into CTMS, ERP, legal systems.

• Provides leadership to one or more Natera initiatives, as assigned.

QUALIFICATIONS:

Provide a list of qualifications that are truly required (e.g. Education and Experience, Equivalent job experience substituted for degree, preferred level to perform principal responsibilities, required certifications to successfully perform principal responsibilities, etc.)

 

• Minimum Education Requirement: Bachelor’s degree in a related field of study.

• Minimum 5 years of working experience managing clinical site budgets and contracts.

• Working knowledge of ICH Good Clinical Practice guidelines.

• Experience with international trials is preferred.

KNOWLEDGE, SKILLS, AND ABILITIES:

Provide a list of technical or behavioral knowledge, skills, and/or abilities. 

Technical: Evaluates an applicant's acquired knowledge and specific technical skills.

Behavioral: Evaluates factors related to human characteristics and skills, such as attitude, work approach and collaborative abilities.