|Job Description||Associate Director/Director, Clinical Data Management Operations|
The Director of Clinical Data Management Operations will provide broad oversight of Data Management Operations to ensure the integrity and quality of Mirati’s clinical data. This individual will collaborate with Clinical Operations and other departments to ensure that the company maintains industry data and quality standards. This individual will work with contracted CROs and maintain the projected clinical trial data management metrics and deliverables.
Oversee the development and quality control (QC) of data management documents including data management plans, data validation specifications, data transfer agreements, and database quality control.
Serves as a data management expert and works with Biostatistics and Clinical Operations departments to ensure data is CDISC/SDTM compliant.
Represent Data Management as the clinical study database expert on Clinical Project Teams.
Oversee the design/program eCRFs, edit checks, and derivations in the EDC databases (following protocol requirements and company standards); perform and document user acceptance testing on databases; oversee database migrations.
Ensure that appropriate data validation (edit check) specifications, quality control checks, and any manual review procedures (e.g., listing review) are implemented and conducted. Participate in Sponsor data review across Mirati clinical trials.
Coordinate with CRO to 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 timelines.
Review all CDM documents within a study area to ensure a consistent approach
Oversee the development of data transfer agreements with central/specialty labs and other external data vendors. Ensuring data quality from data capture to reporting.
Supports review and reconciliation of external data.
Manages Mirati URL to include study set up activities including creation of user environments, access support and provisioning, optimization and update activities.
Develop Clinical Data Management timelines with Program Management 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.
Facilitate the development and implementation of key data and metrics reports/listings for each clinical trial.
Identify, analyze, propose solutions, and effectively resolve complex data issues by exercising appropriate judgment and collaborating with the clinical project team members.
Recommend improvements to CRO Clinical Data Management practices and procedures including identifying and recommending solutions for technology issues.
Perform other duties as assigned.
Comprehensive knowledge of data management practices from protocol design to database development. Proficiency with Medidata Rave (including Architect, Amendment Manager, and Targeted SDV); general understanding of SAS.
Experience working under Good Clinical Practices, Good Clinical Data Management Practices, CDISC/CDASH/SDTM/ADAM, and other FDA guidelines is required.
Demonstrated solid oral and written communication skills and analytical/problem-solving skills are essential as is the ability to clearly communicate basic data management concepts to those outside data management.
Must be able to effectively manage multiple projects and timelines.
Bachelor’s degree in computer sciences or a scientific discipline with a minimum of 6 years of experience in an in-house bio-pharmaceutical clinical data management position is required. Additional experience with oncology clinical trials and working at or managing vendors/CROs is a plus.