Clinical Data Manager - Infectious Disease
Clinical Life Sciences Pharmaceuticals
CY Partners are looking for a Principle Clinical Data Manager to join a world leading global pharmaceutical Organisation based at their site in Uxbridge.
As a Principle Data Manger, you will be delivering the data management components of clinical studies, ensuring high quality data is available to the agreed timelines adhering to industry standard formats. You will have a keen eye for detail and a track record of successful delivery on high profile studies.
Key Responsibilities include:
• Global study level contribution as Data Manager or in close collaboration with the Project or Study Data Manager and other members of the study team.
• Point of contact for complex data management and data quality considerations.
• Provide input to protocol development and other key documents e.g. Monitoring Plan, Protocol Deviation Management Plan, Reporting & Analysis Plan and Data Management Plan
• Manage in-stream data flow activities and deliver a quality database in accordance with the Data Management Plan.
• Be accountable for defining the data capture tools for a clinical study.
• Develop and manages the execution of the validation and integration plan, including dataset definitions and external data sources. Manage vendor performance against Service Level Agreements.
• Be responsible for the set-up and maintenance of the trial master file (TMF) and DM TMF artefacts throughout the study life cycle.
• Input into Oversight plans and manage oversight of CRO, offshore partners and other Third-Party Resources.
• Train monitors and site staff on use of data collection tools and query management process.
• Subject Matter Expert for the Data Management Community in a specified area(s) of functional expertise.
This is an exciting opportunity and we look forward to receiving your application. For further information please feel free to contact Helen at CY Partners on 07851246847 / 0191 477 4733 or you can send your CV to [email protected]