Clinical Data Manager

Description

Key Skills Medidata Rave, Oracle, MedDRA, WHODrug, SDLC
Specifically, the Manager, Clinical Data Management (Study StartUp) is accountable for Gathering of data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data (eCRFs, ePRO, eCOA, etc.), including ensuring adherence to defined standards, and also responsibility for user acceptance testing to ensure high quality deliverables and inspection readiness at all times.
Leading activities with external vendors developing systems/applications for clinical trial data collection (e.g. ePRO/eCOA) to ensure quality and timely deployment.
Bachelors degree required with an advanced degree preferred. At least 4 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.
Global clinical trial knowledge. ImmunoOncology therapeutic experience is highly desirable.
Knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.
An understanding of database and dictionary structures (e.g. MedDRA, WHODrug).
Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
Experience in data management and well versed in industry trends and emerging industry dynamics concerning data review.
A good understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena.
Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).
Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact.