Senior Data Manager

An exciting vacancy for a Senior Data Manager has arisen with an international Clinical Research Organisation (CRO). The establishment, which provides premium support for the management of global clinical trials from phase I to IV, as well as pre and post-marketing medical device investigations, is advertising the position for their European office. This is an exciting opportunity to work with a leading company and provide expertise and skill across the Biometrics field.

Job Responsibilities:

• Design the paper or electronic Case Report Forms (CRF), including paper PROs (diaries, questionnaires), in co-operation with the Sponsor, Project Manager, Statistician, and ICT staff.
• Prepare/review the data management documents (e.g. Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, and Protocol Deviation Handling Document, etc.).
• Prepare and validate the eCRF/clinical databases and related tools.
• Define the requirements and validate the IVRS tool.
• Organise/perform trainings for project team.
• Coordinate/perform data cleaning activities.
• Organise data entry activities, when needed.
• Perform coding activities of medications and medical terms using medical dictionaries.
• Perform SAE reconciliation when required.
• Define the requirements to handle external clinical data and prepare the Data Specifications Document; perform import and reconciliation of external clinical data.
• Perform database locks.
• Prepare, maintain, and archive data management documentation.
• Perform quality control according to the Data Management Plan.
• Liaise with Sponsor and third parties regarding data management activities.
• Track activities and milestones to ensure timely project deliverables.
• Collaborate in establishing and maintaining SOPs related to Data Management.
• Collaborate in establishing and maintaining document/programming standards.
• Contribute to on-boarding of new associates and act as a mentor for junior staff.

Skills and Requirements:

• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Emma Adams at +44 203 854 3893 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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