Clinical Data Associate

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

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 is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. 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.
 
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
 
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.