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
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
Technical: Evaluates an applicants acquired knowledge and specific technical skills.
Behavioral: Evaluates factors related to human characteristics and skills, such as attitude, work approach and collaborative abilities.
Must be self‐motivated with a demonstrated ability to work independently.
Demonstrated analytical skills and ability to identify problems and propose solutions.
Detail oriented, with solid organization, planning, and time management skills.
Ability to handle multiple tasks and deadlines.
Highly effective verbal and written communication skills.
Strong customer focus.
PHYSICAL DEMANDS & WORK ENVIRONMENT
Duties are typically performed remotely or in an office setting.
This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material.
Duties may require working outside normal working hours (evenings and weekends) at times.
Ability to travel up to 25%
Travel required for this position: No