Overview
The Data Manager will cross‑check, confirm data and resolve queries with sponsors and third parties in a timely manner. The post holder will assist with the data management and administration of clinical trials from feasibility to archiving including the efficient set‑up of trial workbooks, completion of case report forms, audit preparation and general trial documentation maintenance.
Key Responsibilities
* Act as point of contact for study sponsors, clinical research organisations and research teams, communicating data queries and monitoring visit requirements.
* Set up and initiate source data workbooks, ensuring version control and accurate record keeping.
* Track payments and complete activity logs for full cost recovery.
* Maintain investigator site files and essential documentation in accordance with ICH‑GCP, Trust SOPs and ensure inspection readiness.
* Keep trial folders, laboratory requisition forms and other documents up to date in line with SOPs.
* Complete team reporting mechanisms (patient visit logs, costings spreadsheets, CRF trackers, electronic proformas, serious adverse events trackers, data entry metrics trackers and workbook trackers).
* Collect and track clinical case notes for all patients for monitoring and audit purposes.
* Ensure data collected meets protocol requirements and is complete and accurate.
* Validate and correct missing or contradictory data and complete case report forms within data entry deadlines.
* Liaise with monitors to ensure data validity and meet monitoring visit requirements.
* Resolve queries by contacting clinicians and health‑care professionals, meeting reporting timelines.
* Support serious adverse event reporting to coordinating centres/sponsors within standard time frames.
* Advise senior team members of concerns related to protocol adherence, data quality, confidential data handling or meeting timelines.
* Assist with audit and inspection preparation within assigned teams.
* Assist Clinical Trial Coordinators with trial document archiving following Trust archiving guidelines.
Qualifications
Previous experience in clinical trial data management, data entry accuracy and a strong understanding of ICH‑GCP, SOPs and audit preparation. IT literate, experienced in administrative tasks, knowledge of the clinical trials process, and a detail‑oriented approach.
Benefits & Diversity
The Christie NHS Foundation Trust welcomes applications from people of all backgrounds and is committed to equality, diversity and inclusion. The Christie values diversity and is committed to ensuring equal opportunities for all and fair representation across the organisation at all levels.
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