Senior Clinical Data Manager (Homebased)

Hobson Prior are currently working with a medical technology organisation who are looking for a Senior Clinical Data Manager to join them on a 3-6-month contract. This position will provide Clinical data management support to Clinical team and/or study project team and the Clinical Data Management team.

Job Responsibilities:

• Accountable to provide data management support to the Clinical Data Management Director.
• 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, Reports and Statistical analysis plans).
• Develop Case Report Form (CRF), 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 (UAT).

Key Skills:

• Computer literate and excellent skills in in Microsoft Office Products and ability to learn proprietary software.
• Attention to detail.
• Ability to work independently and in a team environment with minimal supervision.
• Ability to prioritise tasks.
• Able to work with a global/virtual team.

Requirements:

• Bachelor's degree Science, Ophthalmology or Allied Healthcare Career.
• Experienced clinical data management and/or related work experience in a medical device or pharmaceutical industry/company.
• 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.

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.