Clinical Data Manager

Hobson Prior are seeking for an Clinical Data Manager to join a Biotech organisation to be located in London on a permanent basis. Our client are determined to develop treatments who can save patients' lives.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will contribute to protocol design, protocol and amendment review.
• Be an active member of the clinical study team.
• You will review (e)CRF and ancillary documents related to data collection.
• Follow up on trial timelines from trial start through close out and escalate issues, if required
• Lead/contribute in initiatives on process improvements.
• Participate in regulatory agency and internal audits, when appropriate.
• You will need to check data validation measures for completeness and accuracy, review data safety measures, contribute to definition of protocol deviations.
• Supervise CRO's data collection/review metrics, evaluate SDTM definitions and mapping, perform data content and structure QC.
• Perform final QC on CRO deliverables, ensure completeness of data package before database lock and submission package after lock, finalize all required documentation and oversee transfer and archiving of the data management component of the Trial Master File.

Key Skills:

• High quality standards.
• Strong problem solving and analytical skills.
• Strong communication and interpersonal skills.

Requirements:

• Educated in a BS or MSc in relevant field of life sciences or equivalent by experience.
• At least 2-7 years of experience in DM, experience with at least 1 EDC system, knowledge of SDTM and define.xml is required.
• Knowledge of ICH-GCP, EU and US regulatory requirements.
• CDISC standards knowledge: SDTM and define.xml.
• Accuracy/Precision: data review needs to be meticulous.
• Able to work independently as well as in a team environment.
• Fluent in English, written and spoken.

Apply now:

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.