Clinical Data Management Specialist 9/16/2016
San Diego, CA
JOB DESCRIPTIONDirects the design, documentation, testing, and implementation of clinical data collection methods, and performs clinical database review and query resolution in support of clinical trial efforts.
Designs, documents and implements clinical data studies and clinical database review. (Examples: development of study documentation, development of database specifications, data transfer agreement, and other study documents. Participation in the database validation and UAT, managing the ongoing review of study data, query issuance and resolution, reporting study metrics, handling of electronic transfers, data auditing and database locking.
Serve as a technical liaison between clinical operations and IS specific to the electronic transfer process activities and data warehouse.
Develop Case Report Forms following the dictates of the protocol and collaborates with QA and Regulatory Affairs to refine the required systems and documentation to ensure compliance with SOP’s and regulatory guidelines.
Managing the day to day activities on multiple projects from study start up through database lock.
Analyzes data sets to identify errors, queries, discrepancies and produce reports for their resolution using SAS.
Familiar with the standard concepts, practices, and procedures of clinical research in diagnostics and oncology.
Supports studies and projects in the area of data management process and process of improvement.
Develops, oversees and is accountable for defined Clinical Operations Data Management goals and objectives.
Collaborates and coordinates with others to design and implement clinical protocols and data collection systems to ensure high data quality.
Develops and maintains centralized systems for organizing data to analyze, identify and report data and trends.
Develops library of standard case report form modules and standard data quality plans.
Provides early strategic input into protocol design focused on data management issues.
Oversees, reviews and resolves data discrepancies for standardized data validation systems and procedures.
Supports the assessment of types of resources needed and ensuring adherence to company standard operating procedures and policies.
Provides technical oversight in standardizing processes for data capture and creating efficient workflow solutions.
Supports the implementation of new data management technologies.
Oversees data management projects/activities that have been contracted with outside vendors.
Authors and/or assists corporate data management standard operating procedures (SOPs), other CDM documents, processes, templates and forms.
Develops internal data management reference manuals, working practice documents and completion instructions for tasks not covered in SOPs.
Supports aspects of data management vendor bids and proposals.
Supports management to ensure all deliverables are met by outside vendors/contractors, as defined in the respective executed agreements .
Examines, organizes demonstrations and initiates the implementation of new, innovative technologies, as appropriate.
Insures adherence to all ethical, legal, GCP/ICH, CDISC standards and coding dictionaries (as applicable), as they pertain to data management.
Other duties as assigned.
Position generally requires a Bachelors Degree, in a life science or statistics preferred, with substantial and advanced related experience required. Demonstrated expertise in multiple statistical areas by having 5 years direct data management experience, with at least 3 years experience in a pharmaceutical, biotechnology, or diagnostics business required. Advanced knowledge and experience with SAS, databases, query generation and programming needed. Must be familiar with managing and manipulating large amounts of data and using and writing queries and reports. Experience with quality systems development, assay development, validation and improvement experience strongly desired. Experience working in a FDA, GCP