Careers - CD - Data Manager

Data Manager (DM)

Redmond, WA

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 Data Manager plays a broad role in interfacing with statisticians, clinical affairs representatives, and external partners and vendors to design, configure, and test the clinical database systems. Including support and/or lead clinical database design, data collection and validation, data management and reporting work for clinical trials. The Data Manager will play a key role in oversees CROs and vendors to fulfill responsibilities.

Essential Duties and Responsibilities: 

Provides DM leadership across studies, develops data management strategies and procedures.
Performs DM activities for startup of a study including preparing the eCRF, CCG’s where needed, Data Management Plan (DMP), Data Validation Plan (DVP), External Data Transfer Plan (DTP), etc. and performing user acceptance testing (UAT).
Lead or Performs DM hands on activities during the study on the collection, transmittal, and transfer of clinical trial data and query management; support review and reconciliation of external data; coordinates/leads SAE reconciliation.
Performs Medical Coding as needed, works with CROs and Medical Monitors to coordinate activities for the medical review of clinical trial data.
Organize the data validation meeting, write data validation report, perform the database locking.
Ability to develop SOPs. Regulatory monitoring and ensure compliance with SOPs guidelines (eg. GCP) and regulations.
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 2 years of experience managing large scale data projects for the purposes of supporting research or analysis.
Experience working within a Clinical EDC system (e.g., OpenClincia, Medrio, Medidata Rave).
Knowledge of ICH-GCP, CDISC/ CDASH standards and relevant regulatory guidelines.
Strong knowledge of clinical research, drug development process, and medical terminology, oncology experience preferred.
Knowledge of MedDRA and WHO Drug coding.
Excellent oral and written communication skills.
Project Management skills, ability to manage multiple projects and meet deadlines.
Strong interpersonal, organizational, and communication skills.

The hiring pay range for this position is $80,000 - $170,000 per year based on skills, education, and experience relevant to the role.

SystImmune is a stable, 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.

SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to [email protected]