Senior Biomarker Data Specialist

Seattle Genetics Bothell , WA 98021

Posted 2 months ago

Summary:

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.

Responsibilities:

  • 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

Qualifications:

  • 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

Preferred:

  • 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

  • Oncology experience

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.

#LI-TC1


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Biomarker Data Specialist II

Seattle Genetics

Posted 2 weeks ago

VIEW JOBS 1/3/2020 12:00:00 AM 2020-04-02T00:00 Summary: The Biomarker Data Specialist II (BDS II) is responsible for oversight of clinical specimens and associated laboratory data collected throughout the life of a clinical trial, including safety labs, PK, biomarkers, tumor samples, etc. Responsibilities include collaborating with cross-functional teams to plan, develop and execute lab-related aspects of a clinical trial, as well as specifying and maintaining the system used for sample tracking and reconciliation. A BDS II will oversee the following: 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 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. The Biomarker Data Specialist II has an understanding of clinical laboratory and biomarker testing typical in an oncology setting and is adept at handling specimens and lab data. They also possess a working knowledge of FDA regulations and general industry standards and will support departmental infrastructure development. Responsibilities: * Independently oversee laboratory specimen management and data management procedures. Utilize templates and standard guidelines to initiate documents, but exercise critical thinking and discretion to tailor documents to study needs * Create specifications for study builds in the specimen tracking database, utilizing protocol schedules, sample handling and testing plans, etc. Update and maintain the database as needed, as well as program and generate reports and data reconciliation tools * With minimal oversight, manage multiple project streams, each with their own timelines, objectives and deliverables with minimal oversight. Internal stakeholders may include Clinical Pharmacologists, Biomarker & Bioinformatics scientists, Clinical Project Managers and others * External stakeholders may include vendor representatives such as Project Managers, Data Analysts and others * Advise and coordinate with clinical project managers, scientists, external vendor contacts, programmers, analysts and other stakeholders regarding 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 conduct data cleaning activities for vendor data reconciliation. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths with minimal oversight, 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 * Run SAS programs, review SAS logs, troubleshoot minor errors, and generate output * Demonstrate leadership and problem-solving skills when working with vendors and collaborators to efficiently drive projects forward, overcome challenges and advocate for quality data * Draft, revise, and provide feedback on contracts and study documents to ensure alignment with stakeholders needs, internal processes and vendor capabilities * Support processes and infrastructure for managing external data, including creating templates, flow charts, wikis and other guidance documentation; participate in working groups to develop and implement new processes and applications * Assist in maintenance of department tools, templates, guidelines, SOPs, and systems Qualifications: * Years of experience: 2-7 years; dependent on level of related skills and education * Laboratory background and/or strong knowledge of commonly tested biomarkers in the oncology setting, latest and advanced analytical tools and assays * Effective project management and time management skills; able to prioritize successfully * Prior experience writing specification documents and/or work instructions * Proficiency with data sets and Excel, understanding of data relationships and metadata * Confident in overseeing vendors and communicating with experts to drive quality deliverables * 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 * Can identify opportunities for efficiency improvements and simplification, recognizes appropriate resources for deliverables, has effective organizational skills * Interpersonal skills; encourages 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 * Can learn new skills and knowledge, able to offer new ideas but also willing to adapt style to existing process as appropriate * Preferred: * Software programming or systems development experience * Previous sample tracking and handling experience * Previous Electronic Data Capture (EDC) experience * Working knowledge of the clinical drug development process * Working knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development and UAT * Oncology experience and/or working knowledge * Proficiency with timeline management Education: * BA/BS in relevant field; years of experience may substitute for education 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. #LI-TC1 Seattle Genetics Bothell WA

Senior Biomarker Data Specialist

Seattle Genetics