TEMP - Clinical Site, Contracts Manager

Neurocrine Biosciences•San Diego, CA

About The Position

This is a 6-month temp assignment to cover for a maternity leave. You will provide comprehensive site contract lifecycle management. Responsible for leading the development of clinical site budgets including review, adjustment, and negotiation with clinical sites. Interact closely with clinical study team to ensure timely study startup and with legal department to ensure clinical site contracts are fully executed in a timely manner. Manage administration, negotiation and execution of clinical site contracts ensuring favorable terms regarding study budget, timelines and deliverables including site payments, across multiple projects.

Requirements

BS/BA degree in business administration or health care/science related field and 6+ years of experience in a CRO, Biotech or Pharmaceutical organization.
Experience with contract management, negotiation, budgeting and administration including billing/invoicing, issue resolution, point of contact for CRO, OR Master's degree in business administration or health care/science related field and 4+ years of similar experience noted above
Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
Works to improve tools and processes within functional area
Developing reputation inside the company as it relates to area of expertise
Ability to work as part of and lead multiple teams
Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
Excellent computer skills
Excellent communications, problem-solving, analytical thinking skills
Sees broader picture, impact on multiple departments/divisions
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Excellent project management and organizational skills
Excellent interpersonal and communication skills and experience supporting multiple teams
Strategic thinker who is able to identify issues and improve processes
Ability to work effectively across a matrix organization
Advanced knowledge in Microsoft Word and Excel
Knowledge of Clinical Trial process, regulations and guidelines
Ability to work effectively across a matrix organization
Ability to prepare/negotiate external provider master service agreements, work/change orders, etc. and track for clinical operations
Ability to read and interpret contracts, ensure contract language / terms meet company standards
Strong contract administration skills, including budgeting, billing/invoicing, issue resolution, point of contact for CRO
Knowledge of clinical contract accounting and budgeting process
Solid understanding of drug development and clinical operations

Responsibilities

Ensure timely and successful negotiation and on-going management of clinical site contracts including CDAs, CTAs, CTA Amendments, and other site-contract related agreements as needed in accordance with study timelines.
Collaborate with clinical research sites for in-house run studies, to address site-specific challenges, providing guidance on protocol interpretation and study documentation.
Supports site contract negotiations including triaging, reviewing, and identifying issues for escalation.
Lead the CTA start-up process and develop the CTA and payment terms template, site budget, and supporting documentation to sites and serves as the site contract and budget lead with sites or CRO.
Submit web requests and coordinate with Legal Department on execution of CTAs.
Negotiate site budget with clinical sites based on parameters defined by Head of Clinical Operations (or designee).
Manage site payments for in-house run studies and accounting related activities to ensure payments are made in a timely manner and based on executed site contract.
Collaborate with finance/accounting departments in support of site contract budgets.
Contributes to the development and organization of site contracting and budget/payment processes.
Mentors less experienced team members on all site contract related activities and duties.
Other duties as assigned.