Clinical Data Manager II

General Position Summary/Purpose:

Manages portions and/or all aspects of clinical data management.

Manages portions and/or all aspects of design activities related to trial-specific systems. Creates and delivers system specifications for trial-specific systems.

Manages portions and/or all aspects of development activities related to trial-specific data cleaning plans.

Manages portions and/or all aspects of review and user acceptance testing for trial-specific systems.

Serves as data steward for portions and/or all aspects of assigned trials.

Ensures trial data integrity and quality.

Manages portions and/or all aspects of database lock activities and ensures all lock parameters have been met before lock is executed.

Key Accountabilities/Core Job Responsibilities:

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Manages portions and/or all aspects of 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 portions and/or all aspects of the design of the protocol into the case report forms and clinical technology design specifications for all assigned trials.
• Accountable to produce portions and/or all aspects of 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 portions and/or all aspects of the data cleaning plan across the data collected for assigned trials.
• Accountable for portions and/or all aspects of 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.
• Accountable for portions and/or all aspects of daily operations of an assigned CDM team
• Actively collaborates with stakeholders.
• Accountable for portions and/or all aspects of the identification of needed updates to clinical trial application design specifications and eClinical Solutions and facilitates the implementation of the updates.
• Responsible for portions and/or all aspects of the effective communication for the progress of design, and development and status of a clinical trial.

• Must have 3+ years of direct data management experience (Oncology experience highly desirable).
• Electronic Data Capture (EDC) experience required (BioClinica Express, Medidata Rave, etc...)
• Demonstrated effective communication skills.
• Must have experience designing systems and creating system specifications.

Education and Experience:

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