Description
Sr. Clinical Outsourcing Consultant (Sr. Manager Level)
Support Eisai internal customers in the development of outsourcing requirements for Phase I-IV global clinical trials. 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. Chair proposal review meetings, and coordinate all follow-up activities with service providers during the evaluation and selection process. Evaluation includes cost analysis, capability assessment, and overall alignment of services with project goals. Manage the contracting process including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments.
Coordinate development of service requirements, e.g., statement-of-work, negotiate budgets and payment schedules using costing tools as necessary. Foster clear, consistent and open collaboration across extended Eisai and service provider teams. Engage in service provider relationship and performance management. Support project teams in the resolution of service provider performance issues. Implement, integrate, and maintain department central repository databases for contract tracking purposes, workload management, and metrics tracking. Participate in continuous improvement initiatives and develop and implement tools and processes to achieve Eisai goals. Maintain time and work load tracking. Perform assigned duties and other work related to this position as a Sr. Clinical Outsourcing Consultant.
WORK ENVIRONMENT
Fast paced environment
Collaborative
Business appropriate attire
flex-hours
REQUIREMENTS:
-BA/BS in scientific or business discipline
- Minimum of 5 years of Clinical Outsourcing experience in the Bio/ Pharma industry/CRO environment.
- Ideal candidate will be adept in outsourcing all clinical functional areas (e.g. site start-up, global monitoring, regulatory, study file management, safety, clinical data management, statistics, and clinical reporting) and across a varied service provider base (e.g. CRO, labs, ECGs, imaging and ePRO).
-Excellent business/financial acumen, budget negotiation skills and understanding of the factors affecting the finances and or operations of service providers.
-Excellent communication skills, able to foster and leverage professional relationships and support and influence change at all levels of an organization
-Ability to identify and solve complex contractual, process and operational business challenges
-Demonstrates a customer and team focus
-Demonstrated proficiency in MS Office Suite.
Sr. Clinical Outsourcing Consultant (Sr. Manager Level)
Support Eisai internal customers in the development of outsourcing requirements for Phase I-IV global clinical trials. 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. Chair proposal review meetings, and coordinate all follow-up activities with service providers during the evaluation and selection process. Evaluation includes cost analysis, capability assessment, and overall alignment of services with project goals. Manage the contracting process including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments.
Coordinate development of service requirements, e.g., statement-of-work, negotiate budgets and payment schedules using costing tools as necessary. Foster clear, consistent and open collaboration across extended Eisai and service provider teams. Engage in service provider relationship and performance management. Support project teams in the resolution of service provider performance issues. Implement, integrate, and maintain department central repository databases for contract tracking purposes, workload management, and metrics tracking. Participate in continuous improvement initiatives and develop and implement tools and processes to achieve Eisai goals. Maintain time and work load tracking. Perform assigned duties and other work related to this position as a Sr. Clinical Outsourcing Consultant.
WORK ENVIRONMENT
Fast paced environment
Collaborative
Business appropriate attire
flex-hours
REQUIREMENTS:
-BA/BS in scientific or business discipline
- Minimum of 5 years of Clinical Outsourcing experience in the Bio/ Pharma industry/CRO environment.
- Ideal candidate will be adept in outsourcing all clinical functional areas (e.g. site start-up, global monitoring, regulatory, study file management, safety, clinical data management, statistics, and clinical reporting) and across a varied service provider base (e.g. CRO, labs, ECGs, imaging and ePRO).
-Excellent business/financial acumen, budget negotiation skills and understanding of the factors affecting the finances and or operations of service providers.
-Excellent communication skills, able to foster and leverage professional relationships and support and influence change at all levels of an organization
-Ability to identify and solve complex contractual, process and operational business challenges
-Demonstrates a customer and team focus
-Demonstrated proficiency in MS Office Suite.