Senior Clinical Data Manager 9/6/2016
JOB DESCRIPTIONAPPLY The Senior Clinical Data Manager (CDM) will be responsible for operational execution of clinical data management responsibilities for clinical trial programs including but not limited to the oversight of data management (DM) activities including Case Report Form (CRF) design, database design, developing Data Management Plans (DMPs), CRF annotation, implementing edit check programs, data entry and query status tracking, data quality, and database closure. The Sr. CDM is responsible for tracking important study metrics on data entry, source verification, and query status, and presenting these metrics to a cross-functional team in routine and ad hoc meetings. The CDM role will work collaboratively with biostatistics, clinical, safety, and regulatory groups and CROs, and globally as needed.
Serve as the primary contact for contract research organization (CRO) and vendor interactions, including development of the RFP, defining deliverables, ensuring data quality, problem resolution, and monitoring project activity.
Supports study teams by providing standards for data capture and safety data, assessing the overall quality of data and identifying and escalating key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., frequency of queries and protocol deviations.
Responsible for standardization of DM processes and process improvement and efficiency.
Responsible for the implementation of DM systems (i.e., electronic data capture [EDC]) for clinical trials including database build, CRF development, user acceptance testing (UAT), edit check specification development.
Develops or oversees development of DMPs to define the data collection and processing workflow for clinical studies.
Performs database lock activities to ensure the accuracy and completeness of final clinical trial databases prior to submission to Biostatistics for analyses and submission to the FDA and other regulatory agencies in other countries.
Participates in vendor and technology (e.g., EDC) evaluation, qualification and selection. Supports RFP development, budget and contract negotiation, as needed.
Works in conjunction with the clinical development team on case report form design, data collection processes, query generation procedures, and project timelines.
Develop guidelines and material to support clinical operations in the area of data listing reviews, data analysis, and data presentation.
Oversees related activities outsourced to DM service providers as well as other external data sources (e.g. central and/or specialty labs, IVR vendors, etc.) from study start-up through study close-out and final database lock/transfer/integration
Manages adjudicated safety events and reconciliations between clinical and safety databases.
Act as a liaison with all study members and other functional groups on all levels on technical requirements for database development and data quality within a study.
Accountable for completing project deliverables on schedule, on budget, and according to quality standards and requirements from study start-up through archival.
Responsible for ensuring SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices internally and with DM vendors via regular process auditing. Ensures DM project documentation is in an inspection-ready state.
Oversees the development of data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., data review guidelines, computerized edit check programs, DMPs
Provides input and participates in development of clinical study documents including protocol and monitoring plans, and CRF completion instructions.
Able to cultivate effective and productive working relationships with colleagues, vendors and management. Able to use clear judgment to solve problems and to escalate issues with proposed solutions, as necessary.
Develops SOPs and specific quality processes and procedures for Data Management.
Perform additional duties as needed in support of clinical study teams or department activities.
Bachelor's degree in a related scientific field and at least 7 years significant data management experience or equivalent combination of education & experience. Oncology experience highly desired.
Demonstrated ability to coordinate and monitor the quality of research data collected
Experience in managing and leading DM staff, including contractors and vendors
Knowledge and experience with various clinical databases and key technologies (e.g., EDC, scanning/imaging, CTMS, IVRS/IWRS, CDISC)
Working knowledge of GCP, ICH, FDA, and regulatory guidelines
Excellent verbal communication, writing and interpersonal skills.
Self-sufficient and able to work with minimal oversight.
Proficiency in Microsoft Office applications.
Must be willing to travel as required,