Senior Clinical Data Manager

Role Overview

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. 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.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• 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
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• 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

Requirements

• Bachelors and/or a combination of related experience
• 8+ years’ experience
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Systems knowledge with Medidata Rave and Veeva
• Ability to undertake occasional travel

Benefits

• None specified