Study Data Manager
Paul De Challans is recruiting for a Study Data Manager to join a global pharmaceutical company at their site based in Hertfordshire on a contract basis.
The main purpose of your role as a Study Data Manager will be:
The Study Data Manager (SDM) represents all Clinical Data and Information Sciences (CDIS) functions (including timely database set-up, collection, processing and correction of clinical trials data) and is responsible and accountable for the leadership, planning and delivery of CDIS activities of one or more study(ies) to be completed with high-quality and on time. The SDM is a core member of the Study Management Team (SMT).
- Leads the design of electronic case report forms (eCRFs) to ensure timely delivery of the eCRF to the investigator site for study start.
- Reviews synopsis and protocol ensuring input is provided from all relevant CDIS functions.
- Defines edit check specifications and eCRF behaviours.
- Ensures the eCRF is set-up with the relevant study, site and investigator information.
- Ensures adherence to Global Library Standards, co-ordinates eCRF review and obtains approval from SMT members.
- Determines the level of UAT required and manages UAT activities performed by remote team.
- Leads the development and maintenance of all documentation required to define, setup, and manage the clinical database.
- Creates data review reports and provides metrics as required.
- Ensures all relevant study personnel (internal and external) have access to the eCRF and clinical database.
- Provide support and training to sites on aspects of the eCRF as required.
- Contributes to the set-up and achievement of SMT goals.
- Review of study data, discrepancy management and data cleaning.
- Ensures the reconciliation of all external data with the Data Acquisition Specialist.
- Co-ordinates the reconciliation of SAE data and ensures coding is performed and terms reviewed.
- Review of protocol amendments, performing impact and risk assessment and ensuring input is provided from all relevant CDIS functions. Ensures updates to eCRF are performed within agreed timelines.
- Review of study data to ensure completeness, accuracy and consistency.
- Freeze and lock of study database according to requirements of the SMT (including planned unlocks).
- Perform archiving activities to ensure eCRF data and study documentation is appropriately archived.
For more information or to apply for this position, please contact Paul De Challans on 0114 283 9956 or firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL29862 in all correspondence.