Senior Clinical Data Analyst
New
UK, South Africa, or PolandFull-TimeSenior
Salary195,000 - 223,000 PLN per year
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Job Details
- Languages
- English
- Experience
- At least five years’ or preferably up to 8 years' experience
- Required Skills
- Project Management
Requirements
- Bachelor’s Degree in scientific or healthcare field.
- Proven leadership experience.
- Good project management and multitasking skills.
- 5-8 years of experience in Data Management for pharmaceutical/biotechnology industry.
- High level of Phase I clinical study experience.
- Understanding of ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, and WHO Drug Dictionaries.
- Ability to work individually and within multi-disciplinary teams.
- Strong English language written and verbal communication skills.
- Solid computer system and technical skills.
- Experience with Electronic Data Capture (EDC) systems.
Responsibilities
- Lead a large clinical study or a series of related studies.
- Represent Data Management on the CTWG for assigned studies.
- Provide mentoring and training to lower-level Data Management staff.
- Manage and monitor progress of data management activities with CROs or vendors.
- Review protocols and electronic Case Report Form (eCRF) design.
- Develop or lead the development of the Data Management Plan.
- Coordinate the design and testing of Electronic Data Capture (EDC) systems.
- Perform reconciliation of header data and Serious Adverse Event reconciliation.
- Lead database upgrades and migrations including User Acceptance Testing.
- Perform database lock and freeze activities.
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