Clinical Data Manager III

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:

Manages all (and may be expected to teach some) aspects of clinical data management.

Manages design activities related to trial-specific systems. Creates and delivers system specifications for trial-specific systems.

Manages development activities related trial-specific data cleaning plans.

Manages review and user acceptance testing for trial-specific systems.

Serves as data steward for assigned trials.

Ensures trial data integrity and quality.

Manages database lock activities and ensures all lock parameters have been met before lock is executed.

Acts as team SME for key systems and processes. Acts as team SME for process enhancement efforts.

Key Accountabilities/Core Job Responsibilities:

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Manages the execution of all processes and systems involved in the study start up, data review and database locking of the clinical trial. Effectively communicates progress and expectations around DM Operations processes and the health of the Study.
• Accountable to correctly implement the design of the protocol into the case report forms and clinical technology design specifications for all assigned trials.
• Accountable to produce a data cleaning plan that, when executed as designed, will produce a clinical-trial database that is fit for purpose and adequate for statistical analysis.
• Accountable for the timely application and implementation of the data cleaning plan across the data collected for assigned trials."
• Accountable for the lock of assigned trial databases in a regulatory-compliant manner and in accord with SOPs, process design and time lines.
• Accountable for supporting and utilizing policies and procedures.
• May be Accountable for daily operations of an assigned CDM team"
• Actively collaborates with stakeholders.
• Identifies (and may be expected to teach how to identify) needed updates to clinical trial application design specifications and eClinical Solutions and facilitates the implementation of the updates.
• Responsible for (and may be expected to teach) effectively communicating the progress of design, and development and status of a clinical trial.

Qualifications:

• Must have 7+ years of direct data management experience (Oncology experience highly desirable). Must demonstrate expertise in designing systems and creating system specifications. Expertise in using analytics tools preferred
• Electronic Data Capture (EDC) experience required. Working knowledge of BioClinica Express highly desirable.
• Demonstrated effective communication skills.
• Must demonstrate expertise in influencing teams during the design, conduct, and completion of trials.
• Must have experience leading matrixed teams. Demonstrated effective communication skills.

Education and Experience:

• Bachelor's degree preferred in a health-related or scientific discipline

Equal Opportunity Employer Minorities/Women/Veterans/Disabled