Manager, Clinical Contracts

3 weeks ago

San Mateo, United States Fladger Assoc. Inc. Full time
Job DescriptionJob DescriptionFoster City, CAContract Duration: 12-18 monthsRate: Negotiable

Responsibilities:

  • Excellent employment opportunity for a Manager, Clinical Contracts & Finance III in the Foster City, CA area.
  • Manager, Development Business Operations, ISR/Collaborative
  • Position will be accountable for the drafting, negotiation, and review of global Investigator Sponsored Research (ISR), Collaborative, and related ancillary contracts such as amendments (together referred to as "ISR/CO contracts") including both language and budget, the management of Functional Service Providers (FSPs) involved in the contracting process.
  • Will require oversight of contract activities for multiple clinical development and Medical Affairs programs within the various Company therapeutic areas, ensuring Company Contract Managers and FSP provide adequate level of staff to complete contracts in an accurate, consistent, and timely manner.
  • Must coordinate with the FSPs, the ISR/CO team, Company Clinical Operations and Company Legal departments to manage and complete the site contract process throughout study duration.
  • Responds and resolves complex issues associated with domestic and international contracts with support from more senior staff and Company Legal department.
  • Ideal candidate will have demonstrated success in working collaboratively with stakeholders, especially senior Development Business Operations management.
  • This role can manage the day-today activities in complex ISR/CO contracts and milestone review.
  • Focuses on ISR/CO contracts, amendments, and accountability as it relates to FSP management and site start-up.
  • Works with Functional Service Provider (FSP) to implement ISR/CO contracts Process to ensure efficient delivery of fully executed contracts and amendments.
  • Manages the day-to-day activities of multiple areas in moderately complex clinical contracts and finance.
  • Including but not limited working closely with internal clinical operations and Medical Affairs.
  • Engages in regular, professional communication with stakeholders, including Medical Affairs, to ensure timely negotiations and transparency of negotiation process.
  • Evaluates contract and budget changes requested within ISR/CO contracts and identifies business and/or legal risks manage the issue to resolution by proposing and providing alternative solutions to legal or senior management.
  • Identifies issues/problems and provides recommendations for solutions.
  • Assists other staff in resolving moderately complex issues relating to contract negotiation and management.
  • Ability to develop use spreadsheets and tracking tools.
  • Manages relationships in conjunction with the Clinical Operations as it relates to ISR/CO contracts
  • With the support of internal customers and the legal department, understands and leads the contract negotiation process.
  • Leads the contract life cycle management process for assigned ISR/CO contracts portfolio.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.
  • This role demonstrates an in-depth knowledge of negotiations of ISR/CO contracts, and proficiency in clinical trials agreements.
  • Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development and Medical Affairs.
  • Demonstrates an understanding of the regulatory implications of contracts as related to clinical research.
  • This role must be able to interact on high level with the clinical teams, and project management to provide oversight of negotiations of ISR/CO contracts and related documents.
  • Completes tasks and projects under minimal to no supervision.

Experience:

  • 5+ years of experience with a BA in a relevant discipline.
  • 3+ years of experience with a MS/MBA/JD in a relevant discipline.
  • Relevant experience typically includes contract negotiation
  • Competent in computer skills (Microsoft Office including Excel, Word and PowerPoint)
  • Relevant experience typically includes contract language and budget negotiation, and application of project management principles.
  • Global Site Contracting experience and/or ISR/CO contracts experience a plus.
  • Skilled at Project Management, able to meet deadlines on multiple concurrent projects and work collaboratively with and through others.

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