Senior Clinical Data Manager
ProClinical is seeking a Senior Clinical Data Manager for a biopharmaceutical company that is based in Switzerland.
- Define and manage Clinical Data Management timelines on multiple studies or programs
- Coordinate/perform CDM activities for assigned studies/programs, including eCRF design, EDC system set up, user acceptance testing, users training, database release, data review and query generation and data coding.
- Prepare data management plans, data validation plans and other study specific procedures and guidelines in compliance with standard processes and SOPs
- Ensure appropriate study specific training is provided to assigned study teams and documented
- Ensure ongoing and timely data capture and data cleaning, including external data sources
- Provide/coordinate data management support to study teams to support timely and ongoing data review and monitoring
- Ensure study timelines are met and data quality is according to high industry standards
- Lock, transfer and archive databases.
- Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs.
Skills and Requirements:
- Scientific or technical education background, ideally university level.
- Experience of 5 years minimum in clinical data management, with strong experience using major EDC systems and related tools and technologies.
- Experience leading data management studies and teams to timely deliver quality databases that meet regulatory requirements.
- Good planning, organizational and communications skills
- Ability to effectively work and collaborate in a complex matrix organization
- Fluent in English
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 call Sam Walker on +44 203 8569 336 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Up to Swiss Franc195000 per annum
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