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Clinical Outsourcing Specialist

2 months ago


Trenton, New Jersey, United States Sunrise Systems Full time

Job Title: Outsourcing Manager

Location: Lawrenceville, NJ

Duration: 6 month contract on W2

Onsite position

Job Overview:

This role is focused on managing both in-house and outsourced clinical studies, ensuring alignment with the company's outsourcing strategies within specific therapeutic areas. The position is responsible for fostering partnerships with clinical trial vendors across various service categories in Research and Development.

Key Responsibilities:

  • Lead outsourcing initiatives by collaborating with operational teams, support units, and service providers to ensure effective selection, contracting, and execution of outsourced studies while adhering to regulatory standards and ethical practices.
  • Facilitate project success by meeting short-term goals and maintaining adherence to project timelines.
  • Assist the Outsourcing team with diverse tasks related to outsourcing, alliance management, Functional Service Provider (FSP) operations, and financial/resource accountability.
  • Engage with business partners and internal stakeholders regarding contractual matters as necessary.
  • Provide operational insights and support, as well as training to teams on all facets of outsourced activities.
  • Ensure that teams are aligned with the overarching Client outsourcing strategies.

Qualifications & Experience:

  • A minimum of a BA or BS Degree in Legal, Life Sciences, Business Administration, or a related field. An advanced degree is preferred.
  • 3 to 5 years of clinical development experience in the pharmaceutical, biotechnology, or Contract Research Organization (CRO) sectors is required.
  • Experience in engaging with a diverse range of suppliers, including Contract Research Organizations, cooperative groups, clinical laboratories, and core laboratories, particularly in negotiating and executing legal and financial agreements within the clinical trials landscape.
  • Demonstrated ability to effectively manage key internal and external stakeholders by actively seeking input and integrating feedback into processes.
  • Proven capability in managing cross-functional, multicultural teams and influencing within a matrix organizational structure.
  • Strong time management skills with the ability to adapt to changing job demands, manage multiple priorities, and embrace new initiatives and improvement efforts.
  • Exhibit a high level of adaptability in navigating complex and ambiguous work environments while balancing multiple demands in a professional manner.
  • Ability to maintain high performance levels in a dynamic and evolving environment.