Senior Manager Data Management - Permanent Position

Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology and Pain therapy areas. By joining Eisai, you will be working for an organisation with a human healthcare philosophy, which means that we put the patient first in everything we do.

Your new role

The Senior Manager, Data Management is primarily responsible for the direct management of clinical study activities as they relate to data collection and processing from study start up through ongoing oversight to completion. Working in a highly matrixed environment, the successful candidate must have proven ability to effectively manage outsourced vendor activities as well as internal resources. The candidate must be capable of managing and leading others, providing appropriate feedback when warranted, setting clear direction for team members and appropriately assigning resources to meet work objectives. This individual may also act as “compound lead” for select projects to ensure consistency in the DB build across all protocols, ensuring conformity to Eisai standards.

Develop and review standard Case Report Forms (eCRFs), Data Management Plans, Validation Specifications and Data Transfer Specifications.

Provide Data Management inputs during study protocol development; contribute to the enhancement of a clinical library.

Participate in the development/maintenance of Data Management SOPs, Standard Working Practices, and other Data Management related process documents as needed.

As appropriate, contribute to the selection, oversight of CRO performance related to Data Management activities; act as the sponsor representative for Data Management outsourced activities.

Represent the Data Management function in study teams meetings.

Ensure timely delivery of quality data in accordance with Eisai's SOP, industry standards, and regulatory guidelines.

Work closely with cross functional teams to ensure delivery of quality data; represent Data Management team in study team meetings and provide Data Management questions to internal and external team members.

Execute managerial duties to direct reports and/or provide guidance to members.

What are we looking for?