Are you an experienced Clinical Data Manager who is looking for an exciting career within a rapidly growing CRO?

Our client, an expanding Life Sciences technology company focused on helping companies who run clinical trials, is recruiting for a Senior Data Manager who preferably has Medidata RAVE experience.

The main purpose of the role is to contribute to the development of the data collection and specification from all data sources, manage in-stream data flow activities and deliver a quality database in accordance with the project plan.

What the role involves:

• Designing the Case Record Form and process for CRF approval

• Define and develop the Data Management Plan

• Data Validation Plan with input from study team

• Validation of the database and computerised check

• For EDC studies, define the User Acceptance Test Plan (UA T) and execute the test activities in the test environment to ensure quality eCRF;

• For EDC studies, re-act to issues identified by the eCRF Helpdesk;

• Prepare CRF completion guidelines

• Prepare study specific data-entry guidelines and train data-entry staff for paper studies

• Perform term cleaning for clinical studies, raise manual queries for un-coded terms

• Query management: review open discrepancies, review answered queries, resolve and close where appropriate
  
  

What we are looking for:

• The ability to apply SOPs and guidance documents as well as applicable industry standards like ICH, GCP etc.

• An experienced Data Manager who is a confident user of Medidata "RAVE"

• A person who can lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and prioritising.

• Someone who can Input into and monitor progress against study project plan and escalate issues for resolution at the appropriate level

• SAS knowledge is preferred
  

What the role offers:

• A competitive salary

• Great benefits such as the chance to work with clients internationally

• Generous holiday days offered

You must have a VALID work permit for the U.K. to apply for this role.

If you would like to apply or would like anymore information please call +447 483993113 or email Ryan on ryan@pop-science.co.uk

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