Hobson Prior are currently seeking a Senior Data Manager to join a leading medical technology company that focuses on using the latest technologies helping eye care professionals worldwide improve patient retina care.

Job Responsibilities:

• Study status reporting and metrication of project status for review meetings.
• Create database / clinical trial data specifications, including eCRF design, edit/validation rules/, query logic and data validations, CDASH standards applied to produce annotated CRF.
• Lead EDC database specification process.
• Develop test scripts and execution logs for User Acceptance Testing (UAT).
• Reconcile electronic data transfers from internally and from/to vendor including data reconciliation with in-house data and data transfers.
• Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
• Assist with the maintenance/tracking of user management on and other Clinical databases across allocated Clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.
• Perform training on study trial for EDC and create user guides.
• Preparation of Quality Control Plans to ensure quality checks are implemented and perform as specified in the quality control plan.
• Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock.
• Creation in defining data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
• Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
• Coordinate and communicate with external vendors on a consistent basis to address Clinical teams' requests, project plans, and/or eCRF development activities.

Key Skills:

• Ability to prioritise and manage time sensitive tasks for multiple projects.
• Excellent analytical/problem-solving skills.
• Effective and professional communication skills, written and verbal.
• Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Working knowledge of Clinical database applications such as EDC and CTMS.
• Computer literate and excellent skills in in Microsoft Office Products and ability to learn
• proprietary software.
• Ability to work independently and in a team environment with minimal supervision.
• Ability to work with a global/virtual team.

Requirements:

• Bachelor's Degree Science in related degree required.
• Previous experience in data management and/or work experience in a medical device or pharmaceutical company.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.