Arvinas

External Data Management – Biosample Operations Lead

Arvinas

full-time

Posted on:

Location Type: Remote

Location: Connecticut • United States

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Serves as the Arvinas subject matter expert (SME) and main point of contact (POC) for external data management activities across studies and data interchanges with the clinical database.
  • Serves as the Arvinas SME and main POC for vendor oversight of the central labs and oversight of biosample sample movements between the central lab and analyzing lab.
  • Oversees external data transfer agreements, specifications and data interchanges to the clinical database from 3rd party vendors/analyzing labs. Ensures data transfer specifications are aligned with protocol and analysis requirements.
  • Develops and implements standardized data flows and integration of structured data in the clinical database using standardized, SDTM compliant DTSs for wide variety of data types.
  • Provides ad hoc support for other technical data management activities such as: Arvinas EDC Acceptance Testing, review of EDC data structures for compliance with Standards and SDTM, review of external data file formats, verification of business analytics outputs, etc.
  • Provides Arvinas DM oversight of activities performed by DM CRO/DM Vendors.
  • Reviews and approves DM-related documentation, including contributing to Arvinas Data Interchange Plan and Arvinas Data Review and Data Quality Oversight Plan.
  • Supports clinical study team data review using the JReview application, including user access administration and training; creates and maintains report objects in JReview; creates and maintains Data Listing Repository; provides technical support for data reviewers.
  • Provides operational support for Clinical Study Teams and Biomarker Subteam.
  • Supports process definition, Arvinas SOP and quality document development.
  • Supports vendor contract and work order review.
  • Provides oversight of central lab vendors and central lab vendor databases (LIMS), study documentation review (e.g., Lab Manual) and approval, lab kit review. Ensures alignment of central lab LIMS and the protocol and operational requirements for the study.
  • POC for central lab Quality Events and Quality Incidents.
  • Provides oversight of Analyzing Lab vendors (Data Transfer Specifications development, raw data transfers, biosample movements to/from laboratories).
  • Performs PK biosample tracking for dose escalation clinical studies from Central Lab to PK Lab, in conjunction with Bioanalytical Scientist and Clinical Pharmacology; ensures the availability of biosample results for Cohort Review Committees and decision making.
  • Provides oversight of biosample management and movement, especially between central lab and analyzing labs. Supports biosample movements from laboratories to Biorepository Vendor for long-term storage/biosample archive.
  • Assesses sample loss risk and mitigates sample-related issues with CROs and lab vendors.
  • Creates and approves biosample disposition-related documentation and ensures proper eTMF indexing of sample management/disposition related documentation.
  • Encourages innovation, process improvement, and technology enhancements to increase Drug Development efficiency.
  • Develops and maintains SOPs, Work Instructions, and other quality documents related to data management and biosample management.

Requirements

  • 10+ years of clinical data science/data management, biometrics, and clinical operations experience supporting clinical drug development in an industry setting.
  • In-depth data management knowledge and external data management expertise.
  • In-depth understanding of central lab/analyzing lab processes and laboratory information management systems (LIMS), including biosample requisitioning and accessioning processes and other clinical operations activities.
  • Extensive experience with clinical data interfaces and data exchanges with CROs and other vendors.
  • Extensive experience working with Clinical CROs, analyzing laboratories, and other external vendors; experience creating work orders/budgets, establishing goals, risk mitigation, and ensuring performance standards are met by CRO and vendors.
  • Expert understanding of relational databases. Proficient use of electronic data capture systems (e.g., Rave) and technical skills necessary to perform sponsor acceptance testing. Proficient use of study management tools/web-based vendor dashboards.
  • Proficient use of J-Review; technological skills to create data review and cleaning listings, profiles, data visualizations in JReview.
  • Strong understanding of the complex and interdependent relationships between data collection in EDC systems (e.g., Rave), externally loaded data in clinical databases, and protocol requirements.
  • Strong understanding of data capture standards - CDASH, CDISC, and External Data SDTM standards for clinical study data collection.
  • Understanding of clinical trial management activities and operations
  • Understanding of GCP-ICH, SOPs, regulatory requirements, and Good Data Management Practices, including a strong understanding of 21 CFR Part 11 and GxP complaint systems.
  • Proven experience handling and solving complex problems; implementing solutions & best practices and guiding multiple projects and programs.
  • Excellent written, verbal, and interpersonal communication skills.
  • Strong project management and organizational skills; detail oriented.
  • Strong negotiation skills and effective at influencing decision makers both internally and externally.
  • Ability to work collaboratively and effectively in a cross-functional and culturally diverse team.
  • Must be legally authorized to work in the US without the need for employer sponsorship now or at any time in the future.
Benefits
  • group medical, vision and dental coverage
  • group and supplemental life insurance

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical data managementdata management expertisecentral lab processeslaboratory information management systems (LIMS)clinical data interfaceselectronic data capture systems (e.g., Rave)data review and cleaning listingsdata capture standards (CDASH, CDISC, SDTM)Good Clinical Practice (GCP-ICH)regulatory requirements (21 CFR Part 11)
Soft skills
problem solvingproject managementorganizational skillsnegotiation skillsinterpersonal communicationcollaborationinfluencing decision makersattention to detailinnovationprocess improvement