Seagen
Senior Lab Data Specialist
Development - Bothell, United States
Description
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
Summary:
The Sr. Lab Data Manager (Sr. LDM) is responsible for independent oversight of clinical specimens and associated laboratory data collected throughout the life of a clinical trial including PK, PD, and safety labs. The Sr. LDM independently drives lab-related aspects of a clinical trial by collaborating with cross-functional teams to plan, develop and execute operational objectives. The Sr. LDM manages clinical specimen plans and associated tools in support of study startup/amendments, sample tracking and handling, external lab data transfers, and reconciliation of vendor data with clinical data. They lead operational plans and timelines related to data deliverables and locks. Additionally, they play an integral role in laboratory vendor evaluations and startup, development and review of study protocols and scientific oversight of analytical laboratories. The Sr. LDM has a robust understanding of clinical laboratory and biomarker testing typical in an oncology setting and is adept at handling specimens and lab data. They have in-depth knowledge of lab data management best practices, and general industry standards and will lead departmental infrastructure development.
Principal Responsibilities:
- Independently oversee laboratory specimen and data management procedures. Utilize templates and standard guidelines to initiate documents, but demonstrate critical thinking, alignment-building and discretion to tailor documents to study needs.
- Independently manage multiple studies, each with their own timelines, objectives and deliverables. Manage internal and external stakeholders which may include Clinical Pharmacologists, Biomarker & Bioinformatics scientists, Clinical Project Managers, Clinical Operations and others. External stakeholders may include vendor representatives such as Project Managers, Data Analysts and others.
- Manage and conduct data cleaning activities for vendor 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.
- Work with internal and external stakeholders to coordinate specimen testing in accordance with study plans and timelines.
- Help oversee study vendor collaborations to efficiently drive projects forward, overcome challenges, establish best practices and ensure quality data.
- Create detailed specifications for tabular and unstructured data by working with various stakeholders to ensure appropriate metadata variables and fit-for-purpose data structure that meet end user needs.
- Assist in training and mentoring Lab Data Managers across the department.
- Innovate and lead process/systems improvement projects.
Required Qualifications:
- 2+ years of lab / vendor data management experience
- Previous supervisory experience
- Experience working with or in clinical sample testing laboratories
- Laboratory background and strong knowledge of: LIMS, specimen management and range of biomarkers tested in the oncology setting
- Skilled in project management, leadership, prioritization, and time management
- Prior experience writing specification documents and/or work instructions
- Detail oriented; performs quality and accurate work with minimal oversight
- Excellent written/verbal communication skills
- Can identify opportunities for efficiency improvements and simplification, recognizes appropriate resources for deliverables, has effective organizational skills
Preferred Qualifications:
- BA of BS in a Life Science
- PMP or certification in Project Management
- SAS Certified
As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, visit www.seagen.com.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 07/15/2022
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