Manager, Clinical Outsourcing

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.

We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development.

Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease.

As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.

If this is your profile, we want to hear from you.

Essential Functions

• Supports the development of service provider strategy and outsourcing requirements for Phase I-IV clinical trials (65%) :
• Manages the entire clinical outsourcing lifecycle, including service provider identification, RFI, RFP, service provider evaluation & selection, contract & budget negotiation, performance monitoring, change orders, and contract closeout.
• Drives the contracting process between clinical study teams and service providers (initiation, negotiation, execution, and scope changes) for monetary agreements.
• May support master services agreements with moderate supervision.
• Leads meetings associated with service provider evaluation & selection and contract familiarization.
• Resolves complex issues related to contract negotiation and management.
• Collaborates with study teams, legal, finance, clinical planning, compliance, clinical quality, data protection, IT security and other functions, as required.
• Ensures compliance of work product to SOPs, guidelines, work instructions and GCP and quality standards.
• Manages, under supervision, the development, implementation, and maintenance of outsourcing strategies within the assigned service categories, including service provider governance (10%).
• Contributes, under supervision to process improvement (10 %) :
• Identifies areas for improvement and implements new departmental processes.
• Maintains central databases for contract tracking purposes, workload management, and metrics tracking, provides regular updates, as necessary. (10%)
• Agiloft, quickbase, Veeva eTMF and others as required.
• Supports other assigned tasks that may be required to accomplish departmental goals and objectives. (5 %)

Requirements

• Bachelor's or Master's in relevant discipline with 5+ years of relevant experience; 3+ years' specific to in service provider outsourcing and contract management within the bio-pharmaceutical industry or from a contract research organization or other relevant providers.
• Knowledge of clinical research process and regulatory environment
• Demonstrates business / financial for analyzing and negotiating complex budgets with CROs, Central Labs, eCOA, ePRO, Imaging.

Biomarker. PK, and Biostatistics.

• Proficient in the end-to-end clinical sourcing and contracting process.
• Fluent English (oral and written)
• Experience with working in a matrixed business environment, handling multiple commitments and stakeholders while prioritizing conflicting demands, maintaining focus on the objective, and providing high quality service to both internal and external collaborators.
• Ability to partner in varying time zones, as needed.
• Flexible and proactive
• Must have excellent written and oral communication skills.
• Proficiency in MS Office Suite

LI-TS1

Eisai Salary Transparency Language :

The base salary range for the Manager, Clinical Outsourcing is from : 102,100-134,000

Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https : / / us.

eisai.com / careers-at-eisai / benefits .

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status.

Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States.

Please click on the following link for more information :

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E-Verify Participation