Clinical Data Manager Job at Systimmune, Redmond, WA

ckpYRTRoTTVaRWkyZzk5MXZhYkZjRlVRb1E9PQ==
  • Systimmune
  • Redmond, WA

Job Description

SystImmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA. 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 several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. 

About the position:

The Clinical Data Manager (CDM) plays a broad role in interfacing with clinical study teams, external partners, and vendors to design, configure, and test clinical database systems, conduct data review, and support company deliverables. The CDM will support and/or lead clinical database design, data collection and validation, data management, and reporting work for clinical trials. Additionally, the CDM will play a key role in overseeing CROs and vendors to meet study needs and deliverables.

Essential Duties and Responsibilities: 

  • Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out. 
  • Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Utilize templates and standard guidelines to initiate documents, but demonstrate critical thinking, alignment-building and discretion to tailor documents to study needs.
  • Independently lead data cleaning activities such as, but not limited to, study team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation. Gather cross-functional input to drive creation of custom data review plans. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths.
  • Manage data deliverables processes and database locks, with high quality and efficiency.
  • Foster collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Scientists, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics Scientists, Medical Writers, Regulatory representatives, etc.)
  • DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities. Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct.
  • Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
  • Performs Medical Coding as needed, works with CROs, Medical Monitors, and Clinical Scientists to coordinate activities for the medical review of clinical trial data.
  • Run SAS and/or R programs, review SAS and/or R logs, troubleshoot errors, and generate output. Program SAS and/or R Non-System Edit Checks/Back-end checks and SAS and/or R Data Listings as appropriate for skill level.
  • Evaluate CDM processes and applications for improvements; participate in working groups to develop and implement new processes and applications.
  • Participate in development of DM specific SOPs.
  • Responsible for oversight of CRO data management activities and integrating the various functional group input.
  • All other duties as assigned.

Education/ Experience qualifications:

  • BA or BS and a minimum of 4 years of relevant experience.
  • Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession.
  • Experience working within a Clinical EDC system (e.g., Medidata Rave, Veeva EDC).
  • Experience with managing Lab Data, such as PK, PD, and Biomarkers.
  • Detail-oriented; performs quality and accurate work.
  • Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and GCDMP.
  • Strong knowledge of clinical research, drug development process, and medical terminology, oncology experience preferred.
  • Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials.
  • Knowledge of MedDRA and WHO Drug coding.
  • Project Management skills, ability to manage multiple projects and meet deadlines.
  • Strong interpersonal, organizational, and communication skills.
  • Prior experience writing specification documents and/or work instructions.
  • Previous vendor/CRO management.
  • Previous experience with RTSM, eCOA/ePRO systems.
  • SAS programming experience.


The hiring pay range for this position is $100,000 - $170,000 per year based on skills, education, and experience relevant to the role.

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 discovery or 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. SystImmune offers a comprehensive benefits package. 

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

Job Tags

Full time,

Similar Jobs

LTC Language Solutions

Onsite/Remote Interpreters Needed - All Languages Indianapolis, IN Job at LTC Language Solutions

 ...in both English and another language? Do you have experience working as an interpreter? LTC is an interpreting agency looking for contract interpreters in and around Indianapolis, IN. You will accept appointments on an as needed basis. The ideal interpreter has 3... 

Glass Roots Construction, LLC

Fiber Optic Splicer - Denver, CO Job at Glass Roots Construction, LLC

 ...Glass Roots Construction (GRC) was founded in 2022 by a team of career telecom and construction professionals and is in need of a Fiber Splicer to help us flourish. GRC looks to leverage the latest technologies and utilize the best-in-industry equipment, construction,... 

RSU 71, Belfast, Belmont, Morrill, Searsmont, Swanville

Music Teacher Job at RSU 71, Belfast, Belmont, Morrill, Searsmont, Swanville

2025-2026 Music Teacher Elementary School Level RSU 71 is looking for a Music Education Teacher to work with students in three of the districts elementary schools; A successful candidate will: Be committed to students and their learning. Have experience... 

Stone Canyon Outdoor Edventures

Outdoor Education Instructor - Colorado (Fall 2023) Job at Stone Canyon Outdoor Edventures

 ...We are seeking passionate and enthusiastic individuals to provide the very best outdoor education experience to the students of Colorado! Located between Denver and Colorado Springs and with the Rampart Range of the Rockies as your setting, you will have the opportunity... 

Motion Recruitment Partners

SEO Manager Job at Motion Recruitment Partners

SEO ManagerSan Francisco, CA**Hybrid**Contract$53.33/hr - $66.67/hrExciting SEO Manager opportunity with an established firm.Contract Duration: 3+ MonthsHybrid roles in San Francisco, CARoleWe are seeking a driven, dynamic SEO expert to join our marketing team...