Silverback Therapeutics, a Seattle-based biotechnology company, is seeking a highly motivated Senior Clinical Data Manager to join our Clinical Development Department. This position will support all aspects of data management from study start-up to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer specifications.
- Leads all clinical data management activities for one or more clinical studies.
- Oversees the creation and approval of Data Management study documentation by CROs and other vendors, to include CRFs, completion guidelines, database specifications, edit checks, data review plans, data transfer specifications, SAE reconciliation plans, and external vendor data reconciliation plans.
- Understands all aspects of the study protocols and statistical analysis plans as they relate to data management deliverables and serve as a knowledgeable point person on study teams for data management activities.
- Reviews clinical data and metrics to identify data quality trends, compliance with the protocol, consistency of data across subjects and sites and potential risks to timelines.
- Reviews the deliverables of data management vendors to ensure accuracy and consistency with expected practices.
- Coordinates cross-functional data review meetings with the clinical team. Manage the collection of data issues, reporting of findings and communication of post-review status.
- Produces regular data listings for the clinical team and other functional areas.
- Meets study timelines with a high degree of quality.
- Bachelor’s degree (or equivalent) in relevant scientific discipline preferred.
- Minimum of 5 years of data management experience in the biotech, pharmaceutical and/or CRO setting; oncology study experience preferred, as well as experience with global studies.
- Skills present in core data management activities (e.g., data management plans, edit specifications, utilizing data dictionaries, electronic data transfers, data quality reviews and reporting).
- Knowledge of CDISC and SDTM standard terminology.
- Prior knowledge and experience with frequently used EDC systems, e.g., Medrio, Medidata Rave, Oracle Inform. Experience working with other databases e.g., Central imaging, IVRS/IWRS, ePRO. SAS experience is not required but is preferred.
- Prior experience managing CROs and vendors.
- Knowledge of FDA regulations, GCP, and ICH guidelines required, specifically as it relates to data management.
- Able to work collaboratively and demonstrate leadership skills with internal team and external collaborators, including ability to lead and motivate junior staff.
- Strong team player with demonstrated record of success in a cross-functional team and fast-moving environment.
- Excellent communication, written and interpersonal skills.
- Self-sufficient and able to prioritize and work on multiple tasks & studies with minimal oversight. Uses good judgment in escalating issues to management.
- Able to use established templates and resources to effectively solve problems and recommend solutions for the study team and department leader.
Silverback Therapeutics, Inc. is a clinical-stage biopharmaceutical company leveraging our proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases. Our platform enables us to strategically pair linker-payloads that modulate key disease-modifying pathways with monoclonal antibodies directed to specific disease sites. Initially, we are creating a new class of targeted immuno-oncology agents that direct a myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. We are located in Seattle, Washington. To learn more, visit www.silverbacktx.com.
We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options. Qualified candidates should forward their resumes to firstname.lastname@example.org. We are an equal opportunity employer.