The Clinical Data Manager is responsible for the data collected from one or more clinical trials. Will assist in development of EDC systems used to collect clinical data. During the course of the trial, will review and query the data to insure clinical data collected is clean, accurate and of highest quality possible. Will be responsible for the database lock of their assigned clinical studies and will assist in final clinical study report writing and review. Adverse Event and Medication coding responsibilities may also be considered as part of the job responsibilities.
Key Accountabilities/Core Job Responsibilities:
Participate in protocol review, focusing primarily on data management issues and cross-study data collection consistency.
Participate in the design, documentation, testing and implementation of clinical data collection using electronic data capture (EDC) systems. Includes design of eCRFs, edit check specifications, eCRF Completion Guidelines and Data Management Plans (DMPs).
Responsible for review and resolution of data discrepancies using documented procedures and guidelines.
Works closely with the clinical and statistical programming teams to aid in data analysis programming and data clean up.
Produces study database metrics as requested by the clinical team.
May be responsible for projects that have been contracted with contract research organizations, as well as internal projects.
May be responsible for coding of medications, adverse events and/or medical history using current WHO-Drug/MedDRA dictionaries.
Working knowledge of GCPs, ICH , FDA and regulatory guidelines.
Ability to work independently and under pressure.
Strong verbal and written communication skills.
Consistent, dedicated and able to multi-task.
Minimum 7+ years Data Management experience required. Oncology experience highly desirable.
EDC experience required. Working knowledge of Phase Forward InForm and/or BioClinica Express highly desirable.
MedDRA/WHO-Drug coding experience highly desirable.
Education Requirements (degree, certifications, etc.):
Bachelor’s degree required. Degree in scientific fields preferred.
Pharmacyclics, Inc. - 15 months ago