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Clinical Data Manager
4 months ago
We are seeking an experienced Data Manager with a proven track record in the life sciences industry (CRO, pharmaceuticals, biotechnology, etc). The ideal candidate will possess a deep understanding of Good Clinical Practice (GCP) and its application in research studies. In addition, they will have proficiency in industry-standard clinical database applications, such as Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS). Experience with programming languages like JavaScript or SQL is a strong plus.
Company:
CYTE is a full-service cardiovascular contract research organisation (CRO) powered by an integrated Clinical Research Platform and a Global Site Network. We provide research solutions to our Pharma, Biotech and CRO partners via: CYTE Connect, our integrated clinical platform that allows seamless collaboration for sites, sponsors and CROs; CYTE Locate, our global site network comprising nearly 3,100 sites in 45 countries; and CYTE Accelerate, our specialist CRO services.
Role & candidate profile:
Clinical Data Manager will ensure CYTE studies are planned and implemented to the highest standards, in compliance with ICH-GCP guidelines, CYTE SOPs and all applicable regulatory guidelines.
Responsibilities:
- CRF design, database specification and edit check specification creation based on study protocols.
- EDC build and validation within CYTE’s in-house EDC system.
- Creation of project specific documentation for assigned studies (Data Management Plan, Data Review Plan, CRF completion guidelines)
- Input into study risk assessment and mitigation.
- Reconciliation of data from external sources (e.g. Serious Adverse Events, IVRS, Central Laboratory).
- Data validation and QC
- Liaison with global study sites to resolve data entry issues and ensure query resolution in a timely manner.
- Creation of data transfer specifications and provision of data extracts for statistical analysis.
- Tracking and reporting of study status metrics.
- Ensuring data management documentation is audit/inspection-ready at all times.
- Provide data validation and EDC training for all staff assigned to projects
- Participate in meetings with vendors and study Sponsors.
Desired Skills and Experience:
- Life Science Degree, Nursing qualification, or relevant industry experience
- Experience of Javascript or SQL
- Experience with power BI is desirable
- Excellent attention to detail and ability to apply critical thinking in analysis of data.
- Excellent written and verbal communication.
- Experience with clinical databases, understanding of database structures, programming languages, data standards (CDASH/CDISC) and application of these to CRF design, data handling and reporting.
- Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
- Working knowledge of Clinical database applications such as EDC, CTMS
- Experience in providing training to investigator site staff and in-house.
Candidates must have the right to work in the UK to be considered for this role.
