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Senior Manager, Data Management
6 Month contract with possible renewal
Manager, Data Management – 6 month contract
The Manager of Data Management at Eisai is a DM Generalist. They will need to know all aspects of DM from study start up, interpretation of study protocols, CRF design, UAT, study conduct tasks, managing off shore DMs and all processes related to DM lock. This individual will need to be able to work on multiple projects and ensure aggressive timelines are met. The Manager is an essential part of the study team and must possess good communication skills that include negotiations and an ability to act assertively.
• Experience in addressing technical challenges regarding working with Data Operations staff to correct issues involving Oracle lnform EDC, SDTM mapping, Laboratory data, PK/PD, imaging and
other complex vendor data.
• 6-8 years of experience or more in overseeing DB setup, leading UAT, meeting aggressive
timelines and ensuring the accuracy of essential DM documents.
• Proven experience in meeting challenging timelines and KPls .
Knowledge of Pharmaceutical Regulatory environment and experience as !a key member of a
study team whereby educating teams in the area of standard data processes, and ensuring
• Experience in managing off shore DMs or CRO DMs in an outsourcing model.
Experience in managing vendors and problem solving issues regarding data capture and data
errors found in data transferred from Vendors.
• Experience in therapeutic area, phase I to Ill Clinical Trials, and managing complex study data .
• Embracing and contributing to our culture of process improvements with a focus on streamlining
our processes adding value to or business needs.
• Experience in mentoring and m aging the work of less experienced DMs
• Building successful relationships with cross-functional team members .
• Accountability for quality of data performed and DB build activities by off shore team .
• Engaging appropriate stakeholders in communication while interpreting or updating DM
• Understanding SDTM basis and ability to communicate with technical people involved in Data
Operations support and Statistics.
BS minimum, masters preferred.
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.