Clinical Data Manager III

Pharmacyclics

(Sunnyvale, California)
Full Time
Job Posting Details
About Pharmacyclics
At Pharmacyclics, our every effort is directed to bringing new therapies to life: treatments that help people return to the lives they love as quickly and easily as possible. We believe there is nothing more powerful than giving back in this way. We believe there is nothing more valuable than turning hope into reality and allowing people to focus on the splendor in every day. This is what we call the magic of normal—and we want this for as many people as possible.
Summary
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. Reconciliation of SAE data between the Safety and Clinical databases is also considered part of this job responsibility.
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 use of Standard CRFs, design of study specific Unique CRFs, edit check specifications, CRF Completion Guidelines (CCGs) and Data Management Plans (DMPs) * Responsible for review and resolution of data discrepancies using documented procedures and guidelines. * Works closely with the Clinical Operations, Clinical Science and Biometrics teams to aid in data analysis programming and data clean up * Produces study database metrics as requested by the Study Management Team (SMT) * May be responsible for projects that have been contracted with contract research organizations, as well as internal projects. * Works closely with the Clinical Operations and Drug Safety teams to perform reconciliation of SAE data between Clinical and Safety databases
Ideal Candidate
**Qualifications (Knowledge / Skills / Abilities):** * 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. **Experience/Education:** * 7-10 years Data Management experience required. Oncology experience highly desirable. * EDC experience required. Working knowledge of BioClinica Express highly desirable. * MedDRA/WHO-Drug coding experience desirable. * Bachelor’s degree strongly preferred in a health-related or scientific discipline; however this requirement may be waived for equivalent job-related experience (knowledge, skills and abilities).

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