Senior Manager, Data Management

Eisai•Nutley, NJ

4d•Hybrid

About The Position

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. The Sr. 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.

Requirements

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.

Nice To Haves

Mentoring team members (external/contract staff) on clinical data management activities and procedures

Responsibilities

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.