Proclinical is actively seeking a Lead Clinical Data Manager who will be responsible for ensuring data quality for statistical analysis, supervising data management activities carried out by our CROs, and contributing to the development of the department. This role is crucial in maintaining the integrity of our data and ensuring the smooth operation of our data management processes.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
- Participate in the selection of subcontractors, validate subcontracts and their budgets, and ensure their implementation within set deadlines and with required quality.
- Supervise the Data Management activities carried out by the CROs, from the establishment of the CRF to the freezing of the database.
- Validate the deliverables of the CROs, including Data Management plan, CRF/Database structure, data validation plan, external data transfer specifications, and SDTM specifications.
- Perform User Acceptance Tests (UATs).
- Write external data transfer specifications and reconcile external data.
- Check the quality of the database before the database is frozen.
- Present the progress of Data Management activities to the project team.
- Schedule reports/checks used by the clinical team to ensure data quality.
- Write/Improve Data Management operating procedures.
- Archive documentation related to Data Management activities.
Key Skills and Requirements:
- Degree in Computer Science and/or Science.
- Solid knowledge of Data Management and the clinical field.
- Good understanding of the CDISC standard (SDTM).
- Good knowledge of SAS programming.
- Pragmatic, organized, and rigorous.
- Good ability to analyse and write clear and precise documents to communicate at all levels.
- Ability to meet deadlines.
- Professional English proficiency.
- Excellent teamwork and communication skills.
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.
If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at h.hennigan@proclinical.com.
Proclinical 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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