Reports To: Manager, Clinical Data Management Support
Department/Unit Name: Clinical Data Management
Role Summary: Responsible for assisting in carrying out basic clinical data management activities for assigned projects, ensuring focus on data integrity, validity, reliability in accordance with standard processes, the sponsor guidelines, industry best practices and regulatory standards. Support the department and company in achieving objectives and strategic goals.
Project Support
Assist in essential DM documentation preparation for various trial stages (i.e. start-up, maintenance and closeout)
Assist in basic database and edit check testing activities.
Perform data review and query generation.
Perform data entry where required.
Update database to correct errors.
Assist with generating SAS requests and reviewing report outputs
Assist with generating Data Transfers and reviewing transfer outputs
Assist in the completion of all activities necessary for the finalization and transfer of clinical database and relate project documentation to sponsor.
Ensure approved study documentation is maintained and properly stored in the trial master files.
Department Support
Contribute to the continuous improvement of Data Management and the wider organization through information sharing, training and education.
Promote and be an advocate of Data Management internally and externally.
Qualifications
Applicants should have a minimum of a one-to-two-year post-secondary certification in a relevant field of study, or a minimum of one to three years of related work experience with ongoing training. The successful candidate must exhibit the following skills: self-motivation with strong communication skills and a commitment to achieving positive results. Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results. Ability to engage in continuous learning and self-development. Ability to continually foster teamwork.
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*Accommodations are available for applicants with disabilities upon request throughout the recruitment lifecycle
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