As a member of the team, the CDM will be responsible for supporting all aspects of the data management process while also having the opportunity to further develop industry experience and knowledge.
Work with senior management, technical and client teams in order to determine data requirements, business data implementation approaches, best practices for advanced data manipulation, storage and analysis strategies.
Write logical and physical database descriptions and specify identifiers of database to management system or direct others in coding descriptions. Support development of DM study documentation, including: Data Management Plans, annotated CRFs and specifications, CRF Completion Guidelines, Data Transfer Plans, etc. Support User Acceptance Testing of Database.
Support medical coding and facilitate reviews.
Support SAE Reconciliation.
Support data cleaning activities.
Support DM SAS programming activities.
Provide DM infrastructure support as needed (i.e. policy development, Lab Normal database).
With minimal oversight, develop DM deliverables including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications and Data Review Plans.
Bachelor's degree in a technical field such as computer science, computer engineering or related field required.
Graduate degree preferred.
5-7 years of applicable experience required.
Previous EDC and SAS programming experience desired.
Strong working knowledge of MS Office.
Ability to work independently and with a team.
The successful candidate will be self-motivated and able to multi-task effectively.
Strong interpersonal skills in a team environment.
Knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, the drug development process.