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.
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.
Qualifications:- 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.
- 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.
- 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.
- Oncology experience or interest a plus.
Compensation and Benefits:
The expected base salary range for this position is $75,000 - $95,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's level qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
