Senior Clinical Contracts Manager

Neurocrine Biosciences • San Diego, CA

13d

About The Position

Responsible for leading the development of clinical site budgets including review, adjustment, and negotiation with clinical sites. Interacts closely with legal department to ensure clinical contracts are fully executed in a timely manner. Manages administration / execution of clinical contracts (invoicing, timelines, issues, etc.) across multiple projects. Manages clinical contracts output, tracking and interactions with Accounting and legal teams for consistency across and within Clinical programs. May supervise contract administrators.

Requirements

• BS/BA degree in business administration or health care/science related field AND 8+ 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 6+ years of similar experience noted above
• Anticipates business and industry issues; recommends relevant process / technical / service improvements
• Demonstrates broad expertise or unique knowledge
• Considered an expert within the company and may have external presence in area of expertise
• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
• Ability to work as part of and lead multiple teams
• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture and longer-term impact on division/company
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management, strong project leadership skills
• Expert at managing complexity and multiple work streams in changing circumstances
• Advanced knowledge of Clinical Trial process, regulations and guidelines
• Proven success working effectively across a matrix organization.
• Demonstrated ability to prepare/negotiate external provider master service agreements, work/change orders, etc. and track for clinical operations
• Ability to read and interpret highly complex, variety of clinical contracts, ensure contract language / terms meet company standards.
• Expert contract administration skills, including managing budgets, billing/invoicing process, issues through resolution, act as point of contact for CRO(s)
• Advanced knowledge of clinical contract accounting and budgeting process
• Advanced understanding of drug development and clinical operations

Responsibilities

• Manages clinical trial contractual negotiations including triaging, reviewing and identifying issues for escalation across multiple projects
• Manages and ensures on-time processing of all clinical contracts from initial request through execution in accordance with the project timelines
• Attends clinical operational meetings as needed to advise on clinical contracting activities across multiple projects and vendors
• For studies that are outsourced, manages CRO contracts, site and budget agreement activities and serves as a primary contact and budget liaison between CRO, company legal and clinical operations
• Oversees the CTA start-up process. Development and routing of CTA templates, budget grids and supporting documentation sent to sites.
• Serves as escalation contact with sites for contracts.
• Submits web requests and coordinates with Legal Department on execution of CTAs
• Collaborates with Head of Clinical Operations (or designee) in managing work orders, service agreements, consulting agreements, license agreements, MSAs and CDAs
• Oversees and guides budget negotiation with clinical sites based on parameters defined by Head of Clinical Operations (or designee)
• Collaborates with finance/accounting departments in support of contract budgets and monthly/quarterly reviews
• Manages invoices associated with clinical trials and ensures payments are made based on executed contracts
• Contributes to process efficiencies and organization of contracting and budget/payment processes
• Mentors and appropriately delegates/collaborates cross functionally on assignments for growth of direct reports
• Leads onboarding process for clinical contracts personnel
• Other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior