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Clinical Senior Manager
Description: 1 year contract with possible renewal.
The Senior Manager, Clinical Outsourcing, will lead and manage with minimal supervision activities related to the qualification of service providers and the outsourcing of clinical services including negotiation, and maintenance of contracts for Clinical Research Organizations (CROs) and functional service providers for the Neurology Business Group. This role will foster clear, consistent and open collaboration with Eisai and service provider staff to ensure the most optimal solutions are achieved.
a. Support the development of outsourcing requirements for Phase I-IV global clinical trials including functional services.
b. Lead and support the qualification and evaluation process for service providers.
c. Lead with minimal supervision the process of Request for Proposal (RFP) development from service provider selection through final contract execution.
d. Manage the contracting activities including preparation, finalization, and administration of CDAs, MSAs, service agreements, work orders, change orders, and amendments.
e. Negotiate services descriptions, budgets and payment schedules using costing tools as necessary.
f. Facilitate study kickoff/familiarization meetings to clarify timelines, statement-of-work, roles and responsibilities, and budgets.
g. Support project teams in the resolution of study specific service provider performance issues.
h. Facilitate or attend lessoned learned meetings as necessary to incorporate improvements in new projects.
i. Monitor outsourcing environment to keep current on providers and industry trends.
j. Collaborate effectively with all relevant functional departments (e.g. Finance, Legal etc.) to ensure appropriate review and approval of clinical vendor contracts.
k. Maintain central database for contract tracking purposes, workload management, and metrics tracking, provide regular updates as necessary.
• BA/BS in scientific or business discipline required
• Direct experience (5 years minimum) in managing service provider qualification process and clinical service provider 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 with an eye for detail.
• Strong understanding of financial and compliance standards.
• Able to work with minimal supervision
• Highly organized 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
Eisai requires all contractors providing services to Eisai to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date to their employer/supplier, to the extent permitted under applicable law. This requirement is a condition of providing services to Eisai, and it applies regardless of whether the contractor is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualified medical reasons (including pregnancy-related) or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation from your employer/supplier.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.