Clinical Outsourcing Manager

5 days ago

Nutley, New Jersey, United States Eisai Full time
Job Summary

The Senior Manager, Clinical Outsourcing, will lead and manage activities related to the outsourcing of clinical services, including negotiation and maintenance of contracts with Clinical Research Organizations (CROs) and functional service providers for the Oncology or Neurology Business Group.

Key Responsibilities
  • Develop outsourcing requirements for Phase I-IV global clinical trials, including functional services, and lead the qualification and evaluation process for new service providers.
  • Manage the contracting process, including preparation, finalization, and administration of contracts, and negotiate services descriptions, budgets, and payment schedules.
  • Facilitate study kickoff meetings and support project teams in resolving study-specific service provider performance issues.
  • Monitor the outsourcing environment and stay current on providers and industry trends.
  • Collaborate with functional departments to ensure appropriate review and approval of clinical vendor contracts.
  • Maintain a central database for contract tracking purposes and provide regular updates as necessary.
Requirements
  • BA/BS in a scientific or business discipline required.
  • Direct experience (5-7 years minimum) in managing clinical contracts within the pharmaceutical industry, including experience in negotiating contracts with CROs and technical service providers.
  • Excellent written and oral communication skills, with the ability to form strong cross-functional relationships and influence/persuade others.
  • Flexible and proactive, with excellent analytical and problem-solving skills and a strong understanding of financial and compliance standards.
  • Able to work with minimal supervision and have good leadership and project management skills.
  • Thorough knowledge of GCP/ICH Guidelines and Regulations, as well as the drug development process.

Eisai is an equal opportunity employer and is committed to recruiting, hiring, training, and promoting in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability, or veteran status.

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