Clinical Data Associate
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Overview
Schedule
Full-time
Career level
Senior-level
Remote
On-site
Compensation
$75,000-$95,000/year
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Job Description
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.
- 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.
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FAQs About Clinical Data Associate Jobs at Systimmune
What is the work location for this position at Systimmune?
This job at Systimmune is located in Redmond, WA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Systimmune?
Candidates can expect a pay range of $75,000 and $95,000 per year.
What employment applies to this position at Systimmune?
Systimmune lists this role as a Full-time position.
What experience level is required for this role at Systimmune?
Systimmune is looking for a candidate with "Senior-level" experience level.
What benefits are offered by Systimmune for this role?
Systimmune offers following benefits: Health Insurance, Dental Insurance, Vision Insurance, Disability Insurance, Paid Holidays, Paid Vacation, Paid Sick Leave, 401k Matching/Retirement Savings, and Health & Wellness Programs for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at Systimmune?
You can apply for this role at Systimmune either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.