Clinical Data Associate

Systimmune•Redmond, WA

3d•Onsite

About The Position

The Clinical Data Associate (CDA) supports the Clinical Data Manager in executing data management activities across clinical trials, with a primary focus on Phase 3 and other large-scale studies. The CDA will gain hands-on experience across the full DM lifecycle while working under the guidance of senior data management staff. This role is full-time onsite in Redmond, WA. Please note that SystImmune plans to relocate to a new facility in Bothell, WA in the fall.

Requirements

BA or BS in life sciences, health informatics, or a related field.
1–3 years of relevant clinical data management or clinical research experience; equivalent internship or co-op experience in a clinical or pharma setting will be considered.
Detail-oriented with strong organizational and time management skills.
Effective written and verbal communication skills; ability to work cross-functionally.
Eagerness to learn in a fast-paced, clinical-stage biopharmaceutical environment.

Nice To Haves

Exposure to a Clinical EDC system (e.g., Medidata Rave, Veeva EDC) preferred.
SAS, Python, and R programming knowledge is a plus.
Familiarity with CDISC standards (CDASH, SDTM) and GCP guidelines preferred; willingness to develop deep knowledge required.
Oncology experience or interest a plus.

Responsibilities

Support the CDM in day-to-day data management activities across study start-up, maintenance, and close-out, including tracking open queries and data cleaning timelines.
Assist in the development and review of DM documents such as Data Management Plans, CRF Completion Guidelines, and data review plans using established templates and standards.
Perform data review activities including query generation, query resolution follow-up, and non-system edit check output review under CDM oversight.
Assist with SAE reconciliation and non-CRF data reconciliation activities, escalating issues to the CDM as appropriate.
Support medical coding activities using MedDRA and WHO Drug dictionaries, coordinating with the CDM and CRO for medical review.
Run and review SAS and/or R programs and data listings as directed; assist in troubleshooting basic programming errors under CDM guidance.
Perform UAT (User Acceptance Testing) of EDC systems and edit checks per provided specifications and test scripts.
Assist in tracking and coordinating CRO/vendor deliverables, flagging risks or delays to the CDM.
Contribute to data quality monitoring by reviewing metrics reports and flagging trends or anomalies to the CDM.
Support database lock activities by assisting with lock checklists, outstanding query resolution, and coordination tasks.
Participate in the development and review of DM SOPs and process improvement initiatives.
All other duties as assigned.