We are currently looking for a Clinical Data Associate (CDA) to join our Clinical Data Management team in Glattbrugg. In this role you will report to Senior Director, Data Management and support data management team lead for Data Management activities.
Your tasks will be the following :
Perform all data management tasks as appropriate including, but not to be limited to data review and query management to ensure that quality standards are achieved.
Perform reconciliation of the clinical database against safety data, laboratory data and other third-party data as appropriate.
Review clinical trial data in accordance with Data Management Plans, Edit Check Specifications and / or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete or implausible data.
Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database as required.
May run ancillary programs (metrics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
Interact with other project team members to support the set-up, maintenance, and closure (e.g. Database Lock) of the Data Management aspects of the project and attend meetings as required.
May participate in eCRF Screen Review meetings.
May create, review, and / or execute Form and Edit Check Specification User Acceptance Testing by creating / reviewing dummy data to evaluate EDC database functionality.
Assist in creation of Study Test Plan and Study Test Report documentation.
Modify standard templates to create study specific Data Management Plans, or eCRF completion guidelines.
Filing of Data Management documentation and data management related administrative tasks as requested, including maintenance of TMF as required.
Demonstrate awareness of project schedules and the importance of hitting deadlines.
The ideal candidate will bring the following skills and experience :
Bachelor’s degree in Life Sciences, Computer Sciences, Mathematics, or health-related field preferred
Minimum 3 years of relevant pharmaceutical, biotech or CRO experience
Experience in Clinical Data Management
Knowledge of drug development process preferred, knowledge of science or a scientific background considered
Very good time management skills and ability to adhere to project productivity metrics and timelines
Excellent communication skills in English (oral and written)
You are a team player, you demonstrate high levels of flexibility and work effectively in a cross-functional, cross-regional environment.
You have good organizational ability and interpersonal skills. You have a constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events.
You work in line with the Vifor Pharma values.