External Data Management & Biosample Operations Lead at Arvinas

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Full Time

Start Date

Immediate

Expiry Date

16 Apr, 26

Salary

0.0

Posted On

16 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Management, Clinical Operations, Biosample Management, Vendor Oversight, Clinical Trial Management, Relational Databases, Electronic Data Capture, Project Management, Communication Skills, Problem Solving, Negotiation Skills, Quality Management, Data Standards, Technical Support, Collaboration, Process Improvement

Industry

Biotechnology Research

Description

Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and “undruggable” targets, the company has three investigational clinical-stage programs currently enrolling: ARV-102 for the treatment of patients with neurodegenerative disorders,ARV-393 for the treatment of patients with relapsed/refractory non-Hodgkin Lymphoma and potentially other lymphomas, and ARV-806, a KRAS G12D PROTAC for the treatment patients with solid tumors with KRAS G12D mutations. On August 8th 2025, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for vepdegestrant- an investigational, orally bioavailable PROTAC estrogen receptor degrader- for its use as a monotherapy in the treatment of adults with estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2-), ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the out-licensing and commercialization of vepdegestrant. In April 2024, Arvinas entered into a transaction with Novartis, including a global license agreement for the development and commercialization of the clinical stage PROTAC androgen receptor protein degrader ARV-766 for the treatment of prostate cancer. The transaction closed in May 2024. #TeamArvinas is made up of passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and mission – to improve the lives of patients with serious diseases by pioneering therapies created with our revolutionary PROTAC protein degradation platform. We’re really excited about the work we’re doing inside and outside of Arvinas, and think you will be, too. But don’t just take our word for it – learn more about life at Arvinas and what employees have to say. For more information, please visit www.arvinas.com. Position Summary The position is a multi-disciplinary role that requires in-depth data management knowledge and external data management expertise, knowledge of clinical trial management activities and operations, understanding of central lab/analyzing lab processes and laboratory information management systems to ensure effective integrations and data flow with Clinical Database. The position coordinates and drives collaboration across cross-functional Study Team stakeholders (Data Management/Biostatistics/Programming, Clinical Operations, Translational Sciences, Bioanalytical Sciences, Clinical Pharmacology, CROs, external vendors, etc.) to ensure the collection of protocol-required biosample results and other external data to deliver timely, high-quality clinical study data fit for analysis and reporting. This position reports to the Head of Data Management and can be located at our headquarters in New Haven, CT or work remotely from a location within the U.S. Principal Responsibilities Key responsibilities of this role include, but are not limited to: 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. Qualifications 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. The duties of this role are generally conducted in a home office environment. Employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. Education Bachelor’s degree in quantitative, scientific or health related field required. Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com Arvinas is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, disability or protected veteran status.

Responsibilities

The role involves coordinating external data management activities and ensuring effective data flow with the clinical database. It also includes oversight of vendor activities and collaboration with cross-functional teams to deliver high-quality clinical study data.