Lead- Clinical Data Management

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Job Function:
Data Analytics & Computational Sciences

Job Sub Function:
Clinical Data Management

Job Category:
Professional

All Job Posting Locations:
Irvine, California, United States of America

Job Description:

The Lead Clinical Data Manager will be responsible with leading all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects.

S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets.

POSITION DUTIES & RESPONSIBILITIES:

 Reporting to the Manager, Data Management this individual will:


* Mentor, train and supervise junior associates as needed in clinical data management processes and procedures


* Independently lead several complex trials


* Lead CRF design, review and validation of clinical database, including management of CRO activities in this area as assigned if required


* Be responsible for creation of data management plans and other data management documentation as needed


* Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines partnering as appropriate with Clinical Operations, Franchise and other BSDM functions


* Lead, coordinate, facilitate and manage all data management activities from initiation of protocol through database lock, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects


* Proactively organize and manages ongoing data review throughout study conduct, including being responsible for the correction of errors and discrepancies management for the life of a project


* Proactively identify and address issues that may impact the quality of the data, deliverables or timelines


* Be responsible for identification of data handling processes for non-CRF data, including lab data and image handling


* Work with BSDM leadership, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines milestones and budgets


* Lead efforts co-ordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed


* Independently lead new data management initiatives and contribute towards process improvement, data standards and efficiency gaining initiatives within data...