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Arvinas · 7 hours ago

External Data Management & Biosample Operations Lead

United States

Full-time

Remote

Senior Level, Lead/Staff

10+ years exp

Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. The External Data Management & Biosample Operations Lead will coordinate and drive collaboration across cross-functional Study Team stakeholders to ensure the collection of protocol-required biosample results and other external data for timely, high-quality clinical study data fit for analysis and reporting.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Growth Opportunities

No H1B

Responsibilities

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

Qualification

Clinical data managementExternal data managementLaboratory information management systemsClinical trial managementElectronic data capture systemsRelational databasesData capture standardsProject managementInterpersonal communicationNegotiation skillsOrganizational skillsCollaboration

Required

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

Bachelor's degree in quantitative, scientific or health related field required