Key liaison/Data Management lead to Phase I IV Data Management teams comprising of internal and external Data Management/Data Science resources (DM, Statistical Programmers and Statisticians), Clinical Operations study teams, for the purpose of data management, system development and data cleaning activities across multiple studies.
As a member of the Data Science group - Manage clinical study data or data management projects under aggressive timelines in a high quality and professional manner.
Review protocols and identifies requirements for proper data capture including electronic Case Report Form design and processing of clinical data ensuring accuracy, consistency and completeness while adhering to SOPs and work guidelines as required.
Designs or reviews creation and maintenance of all essential data management documentation including CRF specifications, eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans (detailing complete data management processes throughout clinical studies), Data Review Guidelines, Data Entry Guidelines, Data Transfer specifications and laboratory data handling.
Oversee the design, creation and UAT Plan and testing of clinical study databases along with development of edit check specifications and manual data listings as required.
Responsible for review of medical coding, block cleaning, database lock and freeze, and SAE reconciliation activities performed by external vendors.
Review and approve all DM documentation; maintain all data management internal files, ensuring preparedness for regulatory inspections.
Ability to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.
Functional representative on project teams, study teams, development teams including multi-disciplinary interactions by participating in/leading project meetings to ensure clear overview of progress, risks and mitigation strategies by all participants for all data management related deliverables.
BA/BS, preferably in the scientific/health care field.
At least 4-7 years in Data Management for the pharmaceutical/biotechnology industry.
Experience as lead DM of a Phase I-III studies required; ability to be primary DM representative with little oversight required.
Experience is CNS/Neurology preferred and experience with orphan indications will be favorably considered.
Understands the scope and focus of clinical trials phase 1-4 and has a proven ability to perform the tasks, manage vendor resources and timelines.
Possesses an in-depth understanding of regulatory guidelines e.g. ICH, GCDMP, 21 CFR Part 11 and their application to Data Management practice.
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