Clinical Data Manager

Position Summary: 

The Clinical Data Manager I 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. 

Essential functions of the job include but are not limited to: 

• 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. Provides input and guidance to the design of clinical databases to the client and internal teams
• May perform data entry for paper-CRF studies, as needed
• May perform quality control of data entry
• Adhere to project timelines. Provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation 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. Oversee completeness of data management documentation for the Trial Master File
• 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 SAS programming 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
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Train and ensure 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
• Present software demonstrations/trainings, department/company training sessions, present at project meetings
• Perform all duties in accordance with SOPs, government regulations, guidelines, and industry standards
• May require some travel
• Perform other duties as assigned 

 

Qualifications: 

Minimum Required: 

• Bachelors and/or a combination of related experience 

 

Other Required: 

• 2+ years of experience in data management or demonstrated aptitude in the key skills for the role 
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook 
• Able to handle a variety of clinical research tasks 
• Excellent organizational and communication skills  
• Must be able to read, write, speak fluently and comprehend the English language to enable communication across Prec