Senior Clinical Data Management Associate
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POST DATE 9/16/2017
END DATE 11/5/2018
Neurocrine Biosciences, Inc.
San Diego, CA
This position is responsible for independently performing data management tasks and providing oversight and leadership to support the development, design, implementation, and validation of clinical study databases for both in-house and outsourced clinical trials for all clinical studies/programs
Primary Duties and Responsibilities
Oversee the development and quality control (QC) of data management documents including data management plans, data validation specifications, data management central files, and database quality control.
Represent Data Management as the Lead CDA on Clinical Project Teams.
Ensure that appropriate data validation (edit check) specifications, quality control checks, and any manual review procedures (eg, listing review) are implemented according to standard operating procedures (SOPs).
Develop Clinical Data Management timelines (with management approval) including interim and final database lock and data reviews; monitor overall data management tasks to ensure that timelines are met and that any issues are proactively identified and resolved.
Coordinate and assist with any in-house database design, validation, testing, and edit check programming to ensure that the clinical study database meets protocol and data specifications.
Identify, create, and utilize appropriate reports to ensure data validation and overall project timelines are met.
Identify, analyze, propose solutions, and effectively resolve complex data cleaning issues by exercising appropriate judgment and collaborating with the clinical project team members.
Coordinate and ensure completion of all aspects of data review, including running validation procedures, issuing queries, database QC, SAE Reconciliation, medical coding, and database closure activities according to SOPs.
Follows coding guidelines and utilize all available resources to accurately code, with minimal guidance, Medical History, Adverse Event, and Concomitant Medication data using MedDRA and WHO Drug dictionaries.
Provide data management guidance to the Biostatistics and Clinical Operations departments.
Create and provide input in the development of SOPs, Work Instructions, guidelines, standardization of case report forms and edit checks, and selection and implementation of data management software.
Develop and present at Investigator Meetings and train internal and external users (e.g., sites, CRAs) on the use of EDC.
Recommend improvements to existing Clinical Data Management practices and procedures (SOPs, Work Instructions), including identifying and recommending solutions for technology issues.
Perform other duties as assigned.