Business Analyst (R&D)

pharma client - Sunnyvale, CA (30+ days ago)


Core Job Responsibilities:

  • Technical Lead for GxP applications such as LIMS, CTMS, MasterContol and other similarly classified IT R&D applications
  • Oversee R&D administration and operational support including user and security management.
  • Lead troubleshooting efforts, root cause analysis and impact assessment of R&D production computer applications
  • Work closely with Clinical Apps Manager of IT & R&D Applications to lead initiatives to improve IT R&D effectiveness and efficiency
  • Ability to develop solutions to complex problems that require a high degree of ingenuity, creativity, and innovation within the boundaries of industry compliance regulation
  • Responsible for maintaining the validated state of IT R&D applications to ensure compliance to regulatory standards
  • Responsible for timely closure of IT R&D Exception Reports, CAPAs and Deviations
  • Guide IT R&D as Subject Matter Expert (SME) in the event of Regulatory Audits and Inspections
  • Leading a team of staff including programmers, analysts, and support specialists
  • Implementing and managing security or integrity and backup procedures
  • Identify the criticality of selected application functions and the expected service level goals for application operations and support
  • Consulting computer users to ascertain needs and to ensure that facilities meet user or project requirements
  • Ensuring corporate software licensing policies and procedures are followed
  • Testing and modifying systems to ensure that that they operate reliably
  • Provide expertise in technologies such as SQL, SharePoint solutions, advanced InfoPath design, Workflows, and web programming languages such as HTML, CSS, XML, Visual Basic, and Java.

Other Skills:

  • Familiar with drug discovery, translational medicine, and the regulatory submissions process
  • Experienced with Enterprise wide LIMS/ CTMS/ QMS implementation and support
  • Familiar with Computer System Validation and the Change Control Process in Life sciences industry
  • Should be comfortable working with Business Owners, QA, and users across the organization and with differing levels of technical expertise
  • Advanced understanding of relational databases, database programming skills and tools
  • Strong understanding of the SDLC and Computer System Validation (CSV) and current technology platforms and trends
  • Expected to deliver documentation and training with all solutions
  • Ability to plan and coordinate multiple simultaneous application efforts
  • Quick learner, Analytical and problem-solving skills
  • Strong technical skills
  • The ability to work well under pressure
  • Attention to detail
  • Self-starter / tenacious problem solver / highly motivated
  • Ability to take projects from design to long-term maintenance
  • Ability to work on a team or independently
  • Management and leadership capability
  • Excellent communication and documentation skills

Qualifications, Experience, and Education Requirements (degree, certifications, etc.):

  • Minimum of 5 to 7 years’ experience as a IT R&D Analyst, well-versed with SDLC & iterative systems development methodologies, in the biotech or pharmaceutical industry.
  • Strong experience on relational databases, database programming skills and tools
  • Technical Expertise on SAS/SQL is highly preferred.
  • Strong knowledge of information systems & workflows for processes related to ClinOps, Medical Affairs, CDM, Biostatistics, Clinical Science, and Informatics.
  • Responsible for maintaining the validated state of IT R&D applications to ensure compliance to regulatory standard.
  • Working knowledge of FDA, EMA regulations such as Annex 11, 21 CFR Part 11, Part 210, 211; Computer Systems Validation and GAMP framework.
  • Familiar with electronic ticketing and document management systems such as: Service NOW, Track wise, SharePoint and Microsoft Projects
  • Well-developed business partnering & collaboration skills, adept at establishing & sustaining effective working relationships, both within & between departments.
  • Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors.
  • Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction.
  • Education Minimum BA or BS in relevant life science or computer science required. Advanced degree preferred.

Job Types: Full-time, Temporary, Contract

Education:

  • Bachelor's (Required)