Position Summary
The Biomarker Data Specialist II is responsible for oversight of clinical specimens and associated data collected on clinical trials through managing the process of external data transfers, reconciliation of vendor data with clinical data, leading collaboration to produce specimen management tools in support of study startup/amendments, starting and managing laboratory vendors, developing and reviewing study protocols, maintaining record of all research specimens collected on assigned clinical trials, and oversight of final disposition of research specimens. The Biomarker Data Specialist has a strong understanding of clinical laboratory and biomarker testing typical in an oncology setting and is adept at handling lab data. They also possess a working knowledge of FDA regulations and general industry standards and will support departmental infrastructure development.

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 exercise critical thinking and discretion to tailor documents to study needs
• 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 Specimen Coordinators, Clinical Project Managers and others. External stakeholders may include vendor representatives such as Project Managers, Data Analysts and others
• Lead and conduct data cleaning activities for vendor data reconciliation. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths
• Advise and coordinate with clinical project managers, scientists, external vendor contacts, programmers, analysts and other stakeholders regarding timelines and deliverables
• 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
• Investigate and resolve data discrepancies by working with external labs and internal stakeholders, as well as sourcing appropriate resources
• Use complex problem-solving skills to independently identify creative and effective solutions for issues related to specimens on a project
• Assist in maintenance of department tools, templates, guidelines, SOPs, and systems
• 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
• Work on problems of complex scope requiring in depth evaluation of many variables and balancing of multiple stakeholders and priorities
• Exercises judgement in determining technical objectives of assignments within standard practices and procedures

QualificationsQualifications

• 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:
  • 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

EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.