- 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.
- 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.
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Data Manager - Redmond, United States - SystImmune Inc.
Description
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:
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]
