The Senior Biomarker Data Specialist is responsible for oversight of clinical specimens and associated laboratory data collected throughout the life of a clinical trial. Responsibilities include collaborating with cross-functional teams to plan, develop and execute lab-related aspects of a clinical trial with minimum supervision. The Senior Biomarker Data Specialist independently oversees 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 will manage program level activities, operational plans and timelines related to data deliverables and locks. Additionally, they will support laboratory vendor evaluations and startup, development and review of study protocols and scientific oversight of analytical laboratories. They possess a strong understanding of clinical laboratory and biomarker testing typical in an oncology setting and are adept at handling specimens and lab data. They also have thorough knowledge of FDA regulations and general industry standards and will lead departmental infrastructure projects.
Independently oversee laboratory specimen management and data management procedures. Utilize templates and standard guidelines to initiate documents; exercise critical thinking and discretion to tailor documents to study needs
Independently manage multiple project streams, each with their own timelines, objectives and deliverables
Serve as the functional group point-of-contact for clinical drug program(s) and mentor junior personnel
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
Foster collaboration and relationship-building with cross-functional personnel (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics scientists, Regulatory representatives, etc.)
Advise and coordinate with clinical project managers, scientists, external vendor contacts, programmers, analysts and other stakeholders in order to meet timelines and deliverables
Manage and resolve complex problems that require in-depth evaluation, while balancing multiple stakeholders and priorities
Work with internal and external stakeholders to coordinate specimen testing in accordance with study plans and timelines
Maintain an integrated tracking and inventory log of all specimens collected during a clinical trial, interpret data and share metrics with stakeholders
Lead and oversee vendor collaborations to efficiently drive projects forward, overcome challenges 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
Draft, revise, and provide feedback on contracts and study documents to ensure alignment with stakeholders' needs, internal processes and vendor capabilities. Responsible for facilitating discussions as appropriate
Run SAS programs, review SAS logs, and generate output. Program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level.
Assist in training and mentoring Biomarker Data Specialists I/II and/or contract staff; utilize experience and leadership skills to provide guidance to other team members
Spearhead processes and infrastructure projects for managing external data, including creating templates, flow charts, wikis and other guidance documentation
Innovate and lead process/systems improvement projects
Years of experience: 5 8 years
Experience working or collaborating on clinical research projects; exposure to the clinical drug development field
Demonstrated project management, risk assessment and time management skills.
Clinical testing lab and/or vendor oversight experience
Laboratory and/or specimen management background and strong knowledge of commonly tested biomarkers in the oncology setting, latest and advanced analytical tools and assays
Prior experience writing specification documents and/or work instructions
Proficiency with data sets and Excel, strong understanding of data relationships and metadata
Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession
Detail oriented; performs quality and accurate work with minimal oversight
Excellent written/verbal communication skills
Interpersonal skills; facilitates collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively
Flexible, easily adapts to change, and is energized by challenges and problem solving
Ability to learn new skills and knowledge quickly, able to offer new ideas but also willing to adapt style to existing process as appropriate
BA/BS in relevant field; years of experience may substitute for education
Software programming or systems development experience
Previous Electronic Data Capture (EDC) experience
Understanding of and abreast in FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development and UAT
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics 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.