What You'll Do:
Conduct pre-entry review of clinical data
Review and issue queries for case report form (CRF) data based on automated edit checks, manual review, and sponsor requirements
Ensure accuracy of clinical databases as compared to the CRF and the result of any data queries
Code concomitant medications and adverse events (AEs)
Assist with set-up of data management study files and the collection, transfer, and archiving of study documentation and controlled documents
Maintains all the necessary documentation to support accuracy and integrity of clinical databases
Assist with the tracking of controlled documents (CRFs, data clarification forms [DCFs], etc.)
Assist in defining workflow and processes for all aspects of data management
Collaborate with management to develop and refine departmental SOPs relating to data management
Conduct and direct database development, testing, and validation
Maintain accurate records of all work performed.
What You'll Bring:
Bachelor’s Degree or equivalent in Biological, Behavioral, or Computer science (Minimum of 2nd Class Upper)
Developing computer proficiency in MS Office products (e.g. Microsoft Project, Excel, MS Word)
Ability to learn in a fast paced environment.
strong written and verbal communication skills
Self-motivated with a strong sense of accountability
Maximum flexibility to adapt to changing program needs in real time