Position Summary:
The Clinical Data Manager II manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under some supervision. 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 backup and/or team member.
May perform data entry for paper-CRF studies, as needed
May perform quality control of data entry
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. 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
May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
May review Request for Proposals (RFP), proposals, provide project estimates
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
May present software demonstrations/trainings, department/company training sessions, present at project meetings
May require some travel
Perform other duties as assigned
Qualifications:
Minimum Required:
Bachelors and/or a combination of related experience
Other Required:
5+ years’ Clinical Data Management experience 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 Precision for Medicine…