Priya Mukherjee is recruiting for a Contract Clinical Data Manager to join a successful pharmaceutical company based in Hertfordshire.
Contract Clinical Data Manager Job Description:
Working with this successful pharma company, you will provide a Data Management project management service to the study team by overseeing all the tasks within Data Management.
As a Contract Clinical Data Manager you will also be responsible for the oversight/creation of the Data Management Plan consisting of multiple documents that define how data is captured, processed, cleaned, and closed out. You will also be responsible for ensuring efficient product delivery, thisis on time, within budget, and of high quality.
- Manage database design/ EDC activities and approval of related deliverables.
- Develop and revise Data Management Plan ensuring input and approval from relevant functions. The plan includes, but is not limited to: CRF Completion Guidelines, Quality Control Plan, Serious Adverse Event Guidelines, Edit Check document, and Coding Guidelines. Ensure all activities in the Data Management Plan – either by “hands-on” activity or through coordination – are completed.
- Analyse the results from quality control activities (e.g. metrics, discrepancy/ query analysis, data audits) to ensure that data quality is not put at risk and apply remediation activities if/when required.
- Develop, define, and manage DM related timelines, deliverables, and performance metrics. Critically assess and forecast clinical trial progress and communicate expectations/ deliverables in terms of study milestones.
- Review draft protocol concept sheet and protocol for consistency and assess the implications on DM activities. Coordinate design of these respectively with input from data operations and study team
- Review study financial budget – for DM deliverables only – to ensure that the study deliverables of ‘high data quality, within budget, and according to plan/specifications’ are met.
- Participate in kick off meetings and/ or study team meetings to discuss logistical aspects of trial.
- Support other function activities (e.g., Statistical Analysis Plan (SAP), Tables, Figures, Listings (TFLs)/Tables, Listings Graphs (TLGs) and Clinical Study Report (CSR) review/input).
- Manage delivery of a clean and complete database for lock and statistical analysis.
- Ensure that DM produces study deliverables of high quality, on time, and within budget according to plan/specifications.
- Develop and maintain effective relationship(s) with staff and external vendors, specifically as it relates to Data Management.
- Ensure use of DM standards across trials in the compound program.
- Provide DM insight and expertise to study team across functions and to external partners.
The ideal candidate for this Contract Clinical Data Manager position will have…
- A degree in a Life Sciences discipline (OR equivalent)
- Proven experience of working within the Pharmaceutical industry as a Clinical Data Manager
- Previous experience in managing CROs
- Service Providers, and Technical Vendors.
- Previous experience of working within the Oncology therapy area
- Experience of using Phaseforward’s inform
- A thorough knowledge and understanding of GCP, the clinical research drug development process, clinical study trials, and the role of Data Management and Project Management activities.
- An in-depth knowledge of Data Management procedures, process, and best practices, and an awareness of CDISC and influence on standards.
How to apply:
For more information or to apply for this Contract Clinical Data Manager position, please contact Priya Mukherjee on +44(0)1438 870028 or email firstname.lastname@example.org.