ABOUT US
Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers – headed up by a centralised leadership team.
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. Because our goal is the same as theirs; to improve patients’ lives.
THE ROLE
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.
KEY ACCOUNTABILITIES
* 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.
* Support in the development and mentoring of the team.
* 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.
SKILLS REQUIRED
ESSENTIAL
* 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
* Excellent organisation and time management skills with a high level of attention to detail
* Ability to effectively manage risks and identify solutions
DESIRABLE
* Degree in any Science/Maths subject or equivalent
* Experience with Oracle InForm eCRF
* Experience with SAE reconciliation and medical coding
* Experience of working on oncology and rare disease clinical trials
* Previous experience of coaching and mentoring colleagues
* Previous experience of managing project budgets
* Experience in Sponsor meetings, including Kick-off Meetings and audits
* Experience in reviewing protocols and providing feedback to study teams
* Ability to support process improvement activities
WHY YOU SHOULD JOIN US
Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.
We’re dedicated to bringing the latest advances in science to market. 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.
With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.
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