Apply📍 UK, Spain, Poland, Slovakia, Romania, Hungary, Serbia
🏢 Company: Precision for Medicine
- 8+ years’ experience with strong Oncology and/or Orphan Drug therapeutic experience
- Experience in a clinical, scientific or healthcare discipline
- Dictionary medical coding (MedDRA and WHODrug)
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
- Experience in utilizing various clinical database management systems
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
- 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. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
- 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
- Perform other duties as assigned
Project ManagementSQLData AnalysisData MiningETLSAS EGReportingData entryData visualizationStakeholder managementData modelingData analyticsData management
Posted 1 day ago
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