Senior Data Manager
An exciting opportunity has arisen for a Senior Clinical Data Manager to act as the initial point of contact for the study team for all clinical data related issues. The post holder will introduce new digital technology and innovate data processing tools. This a remote role from either Poland or Spain.
- Ensure data is managed in compliance with applicable standards (e.g. CDISC), regulatory guidelines and OPIS SOPs
- Prepare Data Management documents
- Design the paper and/or electronic Case Report Forms (CRF), including paper PROs (diaries, questionnaires), in co-operation with the Sponsor, and the study team
- Prepare and validate the eCRF/clinical databases and related tools
- Perform data cleaning activities
- Perform SAE reconciliation when required
- Manage database locks and freezing before data analysis
- Prepare, maintain, and archive data management documentation
- Liaise with Sponsor and external stakeholders regarding data management activities
- Track activities and milestones to ensure timely project deliverables
- Organise/perform trainings for project team
- Collaborate in establishing and maintaining SOPs related to Data Management
- Collaborate in establishing and maintaining document/programming standards
Skills and Requirements
- High school diploma
- At least 3 years of experience in CRO, biotech, pharma, research institutes in similar role
- Solid knowledge of clinical data management and HA requirements pertaining to pharmaceutical research and specifically to Data Management
- Digital skills and good knowledge of FDA 21 CFR Part 11 and system validation
- Knowledge of CDISC standard specifications
- Communication skills
- Team-working oriented.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.