Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer. General Position Summary/Purpose:
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. Key Accountabilities/Core Job Responsibilities:
- Participate in protocol review, focusing primarily on data management issues and cross-study data collection consistency. (5%)
- 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). (20%)
- Responsible for review and resolution of data discrepancies using documented procedures and guidelines. (30%)
- Works closely with the Clinical Operations, Clinical Science and Biometrics teams to aid in data analysis programming and data clean up. (30%)
- Produces study database metrics as requested by the Study Management Team (SMT). (10%)
- May be responsible for projects that have been contracted with contract research organizations, as well as internal projects. (<1%)
- Works closely with the Clinical Operations and Drug Safety teams to perform reconciliation of SAE data between Clinical and Safety databases. (5%)
- 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.
- 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).
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Location/Region: Sunnyvale, CA