Consultant Clinical Data Manager
- Contract
- Data Management
- United Kingdom
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Proclinical are recruiting a Consultant Clinical Data Manager for a pharmaceutical organisation. This role is on a contract basis and is located in the UK.
Responsibilities:
- Handle the resolution of data inconsistencies and reconciliation with clinical database.
- Guarantee suitable application of the procedure for access and protection of the clinical data, in compliance with GCP and regulatory needs.
- Responsible for external vendor management.
- Evaluate and validate the data transfer specifications.
- Outline the data management request for submission and review the data management cost estimates suggested by the CROs.
- You will check the compliance of external/internal data with respect to the DTS.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a data management, life science, informatics or similar field, with at least 4-5 years of work experience.
- At least 5 years of experience in a data management role within a biotech, pharma, CRO, hospital center, etc.
- Familiarity with oncology and/or rare diseases would be beneficial.
- Know-how of ICH/GCP, SOPs, and regulatory needs linked to Data Management.
- Expertise on all operational data management aspects of clinical trials.
- Know-how of the CDISC standards, in particular SDTM.
- Acquaintance with eCRF/EDC systems and in SAS programming.
- Fluency in the French and English language.
- Communication skills both verbally and in writing.
- Capable of making decisions within field or accountability.
- Keen on multidisciplinary work focused on team objectives.
- A motivated individual with the ability to prioritise own workload and take own initiative.
- An organised individual who is driven to succeed.
- Capable of working within an ever-evolving setting.
- An adaptable and flexible individual.
If you are having difficulty in applying or if you have any questions, please contact Tom Magenis at +44 203 8541050.
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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