Seagen

Senior Clinical 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 Specialist (Sr. LDS) is responsible for independent oversight of clinical specimens and associated laboratory data collected throughout the life of a clinical trial, including safety labs, PK, biomarkers, tumor samples, etc. The Sr. LDS independently drives lab-related aspects of a clinical trial by collaborating with cross-functional teams to plan, develop and execute operational objectives. The Sr. LDS 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. LDS 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 FDA regulations, clinical data management best practices, and general industry standards.

Principal Responsibilities:

• Independently oversee laboratory data management procedures including authoring data transfer plans, data review plans and overseeing the transfer, processing and storage of data
• 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 project streams, each with their own timelines, objectives and deliverables
• 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 all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics scientists, Regulatory representatives, etc.)
• Lead and oversee 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
• Provide expert feedback on contracts and study documents to ensure alignment with stakeholders’ needs, internal processes and vendor capabilities. Facilitate discussions and gain alignment as needed
• 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. Mentor less proficient SAS users as appropriate
• Investigate and resolve data discrepancies by working with external labs and internal stakeholders, as well as sourcing appropriate resources

Qualifications:

• Minimum 4 years of relevant experience
• Demonstrated leadership, project management, risk assessment, decision-making and timeline management skills
• Experience working or collaborating on clinical research projects; exposure to the clinical drug development field
• Clinical testing lab and/or vendor oversight experience
• Laboratory background and strong knowledge of commonly tested biomarkers in the oncology setting, latest and advanced analytical tools and assays
• Prior experience authoring specifications and implementing new processes
• 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 without 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
• Demonstrated ability to learn new skills and knowledge quickly, able to offer new ideas but also willing to adapt style to existing process as appropriate

Preferred:

• Software programming or systems development experience
• Previous LIMS (Laboratory Information Management System) experience
• Previous Electronic Data Capture (EDC) experience
• Understanding of and abreast in FDA regulations, drug development industry, ICH GCP guidelines, SDTM, CDISC, database development and UAT Oncology experience

Education:

• BA/BS in relevant field; years of experience may substitute for education

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, please visit www.seagen.com.

The hiring pay range for this position is $102,000 - $132,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 09/15/2023