Clinical Research Associate – USA, Permanent Contract!
Clintec is actively recruiting for an Outsourcing Manager to join our expanding global company in the USA on a permanent contract. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.
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 for Neurology Business Group. 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.
Responsibilities of the Outsourcing Manager:
Support NBG in 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
Direct experience (5 yr. minimum) in 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)).
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.