About this role

Develop and review standard Case Report Forms (eCRFs), Data Management Plan, 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 DM 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.

Bachelors degree in sciences or related field with 7+ years of clinical data management experience in pharma/biotech industry OR a combination of equivalent education and experience.
Experience in project management ( i.e. defining plans and milestones, coordinating with cross functional teams and driving accountabilities).
Experience working with clinical trials and the drug development process; understanding of Data Management strategy.
Experience leading data management activities in clinical trials.
Proficient use of data management systems with strong knowledge of data management processes, tools, methodologies and documentation.
Strong experience and knowledge of clinical research, GCP, regulatory requirements and good data management practices.
Some experience with line management; mentoring team members (external/contract staff) on clinical data management activities and procedures preferred.
Proven performance in earlier role.

Senior Manager, Data Management

Key skills