+ industry:Professional, Scientific, and Technical Services
Clinical Outsourcing Manager
The Outsourcing Manager will lead and manage activities related to the outsourcing of clinical services including negotiation, and maintenance of contracts for Clinical Research Organizations (CROs) and functional service providers. Manage the processes which support the implementation and management of global clinical outsourcing. Track budgets, savings, metrics and audit status and performance of external suppliers.
location: Woodcliff Lake, New Jersey
job type: Permanent
salary: $140,000 - 150,000 per year
work hours: 9 to 5
+ Support the development of outsourcing requirements for Phase I-IV global clinical trials including functional services
+ Lead and support the qualification and evaluation process for new service providers
+ Lead the process of Request for Proposal (RFP) development from service provider selection through final contract execution
+ Manage the contracting activities including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments
+ Negotiate services descriptions, budgets and payment schedules using costing tools as necessary
+ Facilitate study kick off/familiarization meetings to clarify timelines, statement-of-work, roles and responsibilities, and budgets
+ Support project teams in the resolution of service provider performance issues
+ Facilitate or attend lesson learned meetings as necessary to incorporate improvements in new project
+ Monitor outsourcing environment to keep current on providers and industry trends
+ Collaborate effectively with all relevant functional departments (e.g. Finance, Legal etc.) to ensure appropriate review and approval of clinical vendor contracts.
+ Maintain central database for contract tracking purposes, workload management, and metrics tracking.
+ BA/BS in scientific or business discipline required
+ 5+ years experience managing clinical vendor contracts within the pharmaceutical industry within a clinical procurement/outsourcing function to include experience in the negotiation of contracts with Phase I-IV CROs, technical service providers, consultants etc.
+ Demonstrates business/financial acumen and thorough understanding of CRO cost models and budget as well as services and costs associated with functional service providers (e.g. IVR, Central Labs, Biostatistics, and Medical Writing, Imaging, ECG, ePRO).
+ Must have excellent written and oral communication skills
+ Team player able to form strong cross-functional relationships, demonstrating an ability to influence/persuade others
+ Flexible and proactive
+ Excellent analytical and problem-solving skills
+ Eye for detail
+ Highly organised with strong negotiation skills
+ Must have good leadership and project management skills
+ Thorough knowledge of GCP/ICH Guideline and Regulations
+ Clear understanding of the drug development process
+ Displays independent thinking and good judgment
+ Proficiency in MS Office Suite
+ 2-3 yrs of clinical vendor contracting experience and 4 years overall experience in Pharma in some capacity (Not expected to have experience in all vendor types or managed Outsourcing for all Clinical Study Phases (1-IV)).
skills: Contract Negotiation
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.