Clinical Data Manager

$100,000 - $170,000/Yr

SystImmune - Redmond, WA

Full-time - Mid Level

Redmond, WA

Chemical Manufacturing

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.

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.
• Independently lead data cleaning activities such as study team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation.
• Manage data deliverables processes and database locks, with high quality and efficiency.
• Foster collaboration and relationship-building with all study team representatives.
• Ensure data management deliverables are met on time.
• Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product.
• Perform 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.
• Evaluate CDM processes and applications for improvements.
• 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.

Requirements

• 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.

Benefits

• 100% paid employee premiums for medical/dental/vision
• STD, LTD
• 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
• 11 paid holidays