Clinical Data Manager (home-based)
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Hobson Prior are currently seeking a Clinical 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. This position will provide data management support to the Clinical Data Management Director.
- Accountability and ownership of data management deliverables on assigned projects to complete the data management activities:
- Preparation and review of study documentation, ensuring all documents are updated/revised/reissued in accordance with any changes to the study/project requirements
- Setup and maintain Trial Master File
- Develops Data Management Plan and Data Handling Manual (DMP/DHM), maintains DMP/DHM throughout lifecycle of study project.
- Study status reporting and metrication of project status for weekly/monthly review meetings.
- Partakes in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reportsand Statistical analysis plans).
- Develop Case Report Form, electronic and/or paper.
- Develop 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.
- Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, UAT summary report
- Reconcile electronic data transfers from internally and from/to vendor including data reconciliation with in-house data and data transfers
- Maintain and tracking of data and images throughout the lifecycle of the study/project.
- Any other assigned tasks.
- Excellent analytical/problem-solving skills.
- Effective and professional communication skills, written and verbal.
- Highly organized.
- Attention to detail.
- Can work independently and in a team environment with minimal supervision.
- Ability to prioritize tasks.
- Ability to work with a global/virtual team.
- You will have 3-5 years clinical data management and/or related work experience in a medical device or pharmaceutical industry/company.
- Working knowledge of Clinical database applications such as EDC and CTMS.
- Programming experience in i.e. SQL, phyton.
- Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Computer literate and excellent skills in in Microsoft Office Products and ability to learn proprietary software.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.