Clinical Data Manager

SystImmune, Inc.; Bothell (WA); On-site; USD 100,000 - 170,000; Full time

Benefits offered by this job

Premium medical/dental/vision coverage

401(k) plan with company match

10–15 PTO days per year

Sick leave

11 paid holidays

Job summary

SystImmune, Inc. in Bothell, WA is seeking a Clinical Data Manager to lead data management activities across clinical trials, interface with study teams and vendors, and ensure data quality from start-up through database lock.

You will develop DM documents, coordinate with CROs, run SAS/R programs, and drive process improvements while onsite in Bothell.

Qualifications

• BA or BS with a minimum of 4 years of relevant experience in clinical data management.
• Experience working with a Clinical EDC system (e.g., Medidata Rave, Veeva EDC).
• SAS programming experience.
• Experience with managing Lab Data (PK/PD, Biomarkers).
• Knowledge of GCP, CDISC standards (CDASH/SDTM/ADaM), FDA/ICH guidelines, and DM lifecycle.

Responsibilities

• Lead all DM lifecycle activities from study startup to database lock and close-out.
• Develop DM documents (DMPs, CRFs, CRF Completion Guidelines, edit checks, UAT specs).
• Perform data cleaning and reconciliation across data sources.
• Manage data deliverables, timelines, and database locks with high quality.
• Collaborate with cross-functional teams and CROs to meet study needs.
• Oversee vendor/CRO activities and coordinate data management tasks.
• Perform medical coding as needed and coordinate with medical monitors.
• Run SAS and/or R programs, generate listings and checks as appropriate.
• Contribute to process improvements and development of DM SOPs.

Skills

SAS programming

EDC systems (Medidata Rave, Veeva)

CDISC standards (CDASH/SDTM/ADaM)

GCP knowledge

Project management

Vendor/CRO management

Data quality / QC

Education

BA or BS degree

Tools

RTSM

eCOA/ePRO systems

Job description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Bothell, 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 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. This position requires you to be onsite full-time in Bothell, WA.

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.

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).
• SAS programming experience.
• 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.

Compensation and Benefits: The expected base salary range for this position is $100,000 - $170,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.

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.