Previous Job
Senior Business Analyst with BioPharma or BioBanks Experience
Ref No.: 17-01658
Location: Hopewell / Pennington, New Jersey
Position Type:Contract
Start Date: 12/07/2017

Project Description:
Client has partnered with a specialty contract research organization (CRO) to deliver specimen tracking and monitoring across all Client studies, which represents a paradigm shift in how Translational Medicine will support our critical biomarker operations within the clinical portfolio. This partnership will enable every newly started study to be fully tracked and monitored for every aspect of sample movement, from collection and earliest shipments through confirmation that data has been generated. This service will deliver flexible dashboards of our specimen performance tailored to each study and ready to be used by our internal Biomarker Operations team to ensure that the entire chain is delivering the biomarker data needed to inform our development in real-time. This partnership also positions Client in a way that is readily extensible to enhance our IT infrastructure that is supporting our biospecimen management - both internally and in collaboration with our primary storage vendors. Client has the opportunity to transition away from a collection of proprietary, in-house built and configured software platforms, and onto a suite of software-as-a-service capabilities made available to us via this partnership. This project begins with an analysis phase that will reveal what gaps exist between the Client requirements and this CRO software suite. This initial analysis will lead into an implementation phase, done using an agile approach, which will require the business analysis team to continue elucidating and specifying the next set of features to be implemented.
In a 5-week timeframe, the business analysis team will assess these aspects of the software suite:
  • Sample Inventory Management and related workflows (intake, fulfillment)
  • Informed Consent setup and reconciliation to permit requested sample usage and define sample retention period
  • Study design, relating to the collection plan for samples across all study events and timepoints
  • Assay Planning, describing which tests need to be run against which samples, and that are offered from vendor catalogs or are developed as novel assays
  • Use of sample annotation data for study-specific and exploratory decision making
  • Sample preparation and processing within laboratories, and associated workflows
  • Integration/data exchange using RESTful API and ETL tools
  • Integration with clinical trial management system
  • Integration with clinical data management system
  • Integration with LIMS
  • Integration with environmental monitoring software
  • Integration with barcode label printing software
  • Integration with eConsent software
  • Incorporate findings from quality and security audit team(s) into implementation plan

Responsibilities – IT Business Analysis
  • Collaborate with IT teams, subject matter experts, and stakeholder scientific groups to understand, gather, and validate formal business requirements, use cases and process flows
  • Coordinate stakeholder assessments and management of stakeholders/sponsors
  • Identify instances where existing processes may be streamlined or improved
  • Articulate and communicate analysis artifacts to development teams (both in-house & vendors)
  • Gather and document integration requirements between CRO software suite and Client systems
  • Create gap analysis between existing CRO software suite and Client Sample Tracking requirements
  • Create implementation plan to transition from Client software to CRO software, identifying components being transitioned, stakeholder groups affected, and timeframes
  • Create data migration plan from Client software to CRO software
  • Create change management and communication plan describing impact to stakeholders that this transition will cause, and what learning is required to enable these stakeholders to be productive using new software

Required Skills:
  1. Experience with implementation and delivery of computer systems at BioPharma companies or BioBanks (academia, industry) used to manage at least one of the following:
    1. Sample Inventory Management
    2. Informed Consent
    3. Clinical Study Design and Sample Logistics
    4. Sample and Assay Planning
    5. LIMS
  2. At least 10 years of prior experience working in an analyst capacity on large and/or complex projects in the Pharmaceutical Industry
  3. Ability to elucidate requirements from a diverse group of scientists and operational support business representatives that span multiple sites and departments, during workshops, interviews, and pilot settings.
  4. Experience in Biopharmaceutical Research and Development industry; in particular a working knowledge of clinical trial data management system, sponsor/CRO/central lab/clinical site interactions, scientific data analysis and reporting.
  5. Experience with Computer Systems Validation, working knowledge of 21 CFR Part 11
  6. Experience configuring or managing Biofortis' Labmatrix and Qiagram products a strong plus.
  7. Experience in an analyst capacity on a large scale COTS project, a custom development project, and/or combination of both (impacting 100+ Users across multiple domains)
  8. Experience with formal SDLC practices, emphasis on Analysis & Design stages, Agile methodology
  9. Experience with planning data migration activities for enterprise systems
  10. Experience with data integration/ETL technologies
  11. Experience with system integration, RESTful API, messaging technologies
  12. Agile SCRUM methodologies experience in a BA capacity a plus
  13. Proven ability in gathering, tracing, translating and managing complex requirements, business rules, and data
  14. Excellent oral and written communication skills including technical writing / documentation; organizes and presents ideas in a convincing, concise, and compelling manner
  15. Exceptional interpersonal skills; able to communicate effectively with both technical and non-technical teams; able to provide technical leadership
  16. Outgoing personality; self-starter able to work interactively and independently with stakeholders
  17. Possess strong business acumen; possess a broad, enterprise-wide view and understanding of strategy, processes and capabilities, enabling technologies, and governance
  18. Bachelors or Masters Degree in computer science, engineering, physical sciences, life sciences, or logistics
  19. Experience with process modeling tools (ARIS, Visio, etc.) to identify, capture, define, and analyze business processes
  20. Strong proficiency in MS Excel, Word, PowerPoint, Outlook

Position Requirements
  • Frequent travel between central NJ sites (Hopewell, Lawrenceville, Princeton Pike).

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Michelle: