Senior Manager, Clinical Outsourcing

1 month ago

Princeton, United States Meet Full time

Position Summary:

The Manager of Clinical Contracts Management oversees all aspects of vendor selection, contracting, and negotiation for agreements essential to the clinical development plan. This role demands innovative problem-solving skills and experience with clinical research phases I-IV. Collaboration with clinical contracts team members, clinical trial teams, and vendors is crucial.

Responsibilities:

  • Partner with clinical trial teams, internal stakeholders, vendors, and investigational sites to ensure timely study start-ups that align with departmental and organizational goals.
  • Key duties include:
  • Develop Investigator Grants budgets based on Fair Market Value benchmark data.
  • Review RFPs for clinical services during the bidding process to assist in selecting CRO vendors, including budget development and contract negotiations.
  • Represent Lilly’s position on budget and contract matters, addressing issues in a frontline capacity.
  • Manage contract escalations using the Negotiation Guidance Document and legal rationale, employing effective communication strategies.
  • Handle budget escalations by applying Negotiation Parameters and standard pricing, providing justifications for Lilly’s stance.
  • Oversee and communicate the status of budget and contract finalization, essential for declaring a site ready for patient enrollment.
  • Ensure CROs adhere to expected study timelines, collaborating with all team members to support study requirements and deliverables.
  • Manage the development and execution of additional agreements as needed.
  • Act as a liaison between clinical service groups (SMOs, CROs), legal teams, and clinical trial teams for outsourced trials when necessary.
  • Navigate complex negotiations and resolve critical issues with external parties.
  • Develop and apply innovative contract and budget strategies to address complex issues.

Basic Requirements:

  • Bachelor’s degree in business administration, finance, science, or a related field; equivalent work experience may be considered; advanced degree is a plus.
  • 5-7 years of experience in pharmaceutical services, including at least 2 years in contract management or study start-up activities, encompassing contract negotiations and management.

Additional Preferences:

  • Strong organizational, analytical, and team management skills.
  • Proficiency in handling complex budgets.
  • Competency in document and spreadsheet applications.
  • Experience managing complex, multi-faceted projects.
  • Demonstrated negotiation skills and extensive knowledge of clinical trial agreements.
  • Proven ability to collaborate effectively with professionals across functions and teams.
  • Excellent written and verbal communication skills.
  • Ability to multitask and adapt priorities to meet tight deadlines.
  • Professional demeanor, attention to detail, and organizational skills.
  • Enthusiastic, self-motivated, and committed to improving processes and resolving inefficiencies.
  • Proficiency in Microsoft Office Suite and applications.

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