Senior Manager

4 weeks ago

United Kingdom Simbec-Orion Group Full time

Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. We are looking for a Senior Data Manager to join our Biometrics Department where you will be responsible for leading all data management activities for assigned clinical studies, for all aspects of the study from eCRF Design, review and testing, all aspects of data review and database lock procedures. You will deliver presentations at sponsor meetings, support data management activities to the Principal Data Manager and Team Leads and will support colleagues' development across the department.

Manage the workflow for allocated studies, adheres to agreed study timelines and flag potential problems to the department head, Data Management Team Lead and Project Manager, as appropriate.
Participate at sponsor meetings, including Bid Defence Meetings, Kick-off Meetings and audits, to provide input from a Data Management perspective and to present the data management processes as required.
Prepare data management documentation, for example, Data Management Plans, eCRF User Guides and Data Transfer Plans and other supportive study documentation.
Communicates clinical data and quality issues to the Data Management Team Lead.
Act as point of contact for internal and external customers for all data management tasks and issues for allocated studies.
Support Department Head and Data Management Team Lead in reviewing and updating SOPs and process improvement initiatives.
Manage and review the testing of the data entry screens for new databases.
Perform database lock procedures.
Provide solutions to issues that arise during the conduct and analysis of the study.

Previous experience in data management within the pharmaceutical industry or a clinical research organisation
Experience in a Lead Data Manager role
Experience of working on studies using Electronic Data Capture (EDC) or paper databases
Experience in study build, study conduct and database lock activities
Experience in data review and reconciliation
Fluent English - Excellent written and verbal communication skills with the ability to communicate with all levels across the organisation
Ability to effectively manage risks and identify solutions
Experience with Oracle InForm eCRF
Experience with SAE reconciliation and medical coding
Previous experience of managing project budgets
Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company – and your reason to be a part of it.

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