Position Overview
The Exact Sciences Biorepository team enables the execution of clinical trials and research initiatives by delivering high-quality services across the sample management lifecycle. The Sr Biorepository Informatics Manager plays a key role in enabling efficient Biorepository operations and service request fulfillment by overseeing the design, development, and maintenance of data infrastructure systems for collection, integration, reporting, and analysis. The Sr Biorepository Informatics Manager also ensures strategies, tools, and related procedures align to enterprise data standards and initiatives. This position requires strong attention to detail and collaboration skills, and technical expertise including, but not limited to, data architecture design, programming, interoperability, quality assurance, and innovation.
Essential Duties
- Build strong relationships with cross-functional stakeholders and strive to establish Biorepository as a critical business partner.
- Educate stakeholders on Biorepository capabilities, operating norms, and opportunities.
- Engage with Exact Sciences’ cross-functional teams, such as Research and Development, Clinical Affairs, Laboratory, IT, and Enterprise Data, to ensure projects and activities remain complimentary and strategically aligned.
- Design, develop, test, and maintain data infrastructure systems to support efficient collection, storage, management, retrieval, analysis, and reporting of Biorepository-related data.
- Execute system development lifecycle procedures, including requirements gathering, risk assessment, and programming validation. Document necessary cross-functional approvals for specification documentation.
- Integrate data (i.e. clinical demographics, sample processing, sample storage, use parameters / approvals, test results) across multiple sources on a unified platform while adhering to regulatory and security requirements.
- Harmonize data to industry standards to facilitate interoperability with other systems.
- Develop scalable, automated ETL pipelines to streamline the collection / extraction, transformation, and compilation of data while minimizing manual effort and error.
- Develop and implement robust data validation checks to systematically detect data discrepancies and gaps; perform root cause analysis and implement corrective actions.
- Ensure data infrastructure can scale and handle increasing load as Biorepository collections expand.
- Monitor system latency and processing speeds; partner with appropriate teams to identify and resolve performance issues quickly.
- Serve as a main point of contact for Biorepository data-related services and matters.
- Pull, compile, analyze and visualize large datasets for reporting to customers, internal stakeholders, and project teams.
- Enable the development of automated and/or self-service data reporting tools to improve access to and understanding of Biorepository data among stakeholders.
- Develop and maintain KPIs; leverage measurements alongside partner feedback to refine and improve service models.
- Provide data-based insights to program leadership as necessary to support strategy and decision-making.
- Keep current with cutting-edge techniques in programming, machine learning, big data, and modeling and seek ways to advance Biorepository data-related capabilities.
- Explore and incorporate AI-driven data solutions to innovate Biorepository operations.
- Evaluate, propose solutions to, and act upon process improvement opportunities that address inefficiencies and drive operational excellence.
- Lead and/or support Biorepository initiatives including but not limited to program expansion, quality improvement, process improvement, document development, and support requests.
- Lead cross-functional project teams by defining scope, providing executable tasks and risk mitigation measures, developing milestones, and ensuring completion deadlines are met.
- Develop, review, and upkeep SOPs, technical documentation, process maps, data dictionaries, and user guides to ensure a comprehensive knowledge base.
- Provide training and technical guidance on data-related procedures and best practices.
- Possess a positive attitude with excellent interpersonal skills and the ability to interact and build strong working relationships with customers as well as peers at all levels of the organization.
- Listen, influence, negotiate, and mitigate conflict while building relationships achieving desired results.
- Adapt to rapid changes in priorities, display strong sense of urgency, and can identify ways to work together to achieve results needed for all requests per defined deadlines.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Maintain regular and reliable attendance.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability and means to travel between local Exact Sciences locations.
- Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
Minimum Qualifications
- Bachelor’s degree in Computer Science, Information Systems, Data Engineering, Biological Science or a field as outlined in the essential duties; or Associate’s degree in Life Sciences or a field as outlined in the essential duties and 2 years of experience; or High School Degree/General Education Diploma and 4 years of experience.
- 5+ years of experience in informatics, database architecture design / management, or LIMS administration.
- Strong knowledge of data tracking, extraction, transformation, cataloging, analysis, and delivery.
- Experience with programming languages (i.e. R, SAS, Python, SQL, Java).
- Experience with cloud-based data platforms (i.e. Databricks).
- Experience with data visualization tools (i.e. Tableau, Power BI).
- Experience working with structured and unstructured datasets from various sources.
- Excellent attention to detail and data accuracy.
- Strong problem-solving skills with a focus on process improvement and operational efficiency.
- Excellent collaboration skills to work across teams and with customers.
- Ability to convey technical concepts to both technical and non-technical stakeholders.
- Strong project coordination skills with the ability to motivate and guide team members without direct reporting authority.
- Ability to thrive in a fast-paced, evolving environment, and manage competing priorities.
- Advanced proficiency in Microsoft Office programs, such as Word, Excel, Outlook, and PowerPoint.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
Preferred Qualifications
- 7+ years of industry experience in a field as outlined in the essential duties.
- 1+ years of experience leading indirect or direct teams.
- Experience with data management / engineering in a Biorepository or clinical research environment.
- Experience in a customer-facing support role.
- Experience conceptualizing, documenting, and presenting creative solutions to senior management.
- Experience leading project involving complex business workflows and/or system architectures.
- Professional working experience with 21 CFR Part 11 compliant software.
- Understanding of HIPAA, CDPR, and FDA guidelines for data protection.
