Lead Data Manager (Remote)
Contact: Neisha Camacho/Terra Parsons
Job Summary: The Clinical Data Manager manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under some supervision. This work will be performed in the CDMS (data collected via Electronic Data Capture (EDC) and/or paper CRFs) selected for the study trial. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.
Primary Data Management (DM) contact (Lead DM role) and/or contributor for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member.
Adhere to project timelines
May provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed.
Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
May assist in building clinical databases
Conduct database build UAT and maintain quality controlled database build documentation May oversee overall quality of the clinical database.
Specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.
Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
Review and query clinical trial data according to the Data Management Plan
Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
Run patient and study level status and metric reporting
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
Coordinate SAE/AE reconciliation
Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
May assist with running SAS programs and quality control of SAS programs used in the Data Management department
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
Trains and ensures that all data management project team members have been sufficiently trained
Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
Performs all duties in accordance with SOPs, government regulations, guidelines and industry standards.
May perform other duties as assigned.