Program Senior Analyst - R&D
General Position Summary/Purpose:Pharmacyclics is seeking a IT R&D Sr. Operations Analyst who will play a critical role in R&D client engagements and in core operational activities for the IT R&D projects. Accomplishes objectives by designing and monitoring the planning, configuration, and deployment of our Clinical Trials Management System (CTMS), Laboratory Information Management Systems (LIMS), Quality Management Systems and other systems in support of associated core R&D functions and processes. This resource will be the Technical Lead for above systems and will collaborate closely with various R&D Business functions, other IT resources, IT Infrastructure, Project Management, vendors, end users and QA and IT Validation groups .
Strong GxP knowledge, and technical, organization, analytical and communication skills are key to successful performance in this position, which is under the direction of the IT R&D Clinical Apps Manager, who provides leadership on each client engagement.Core Job Responsibilities:
Technical Lead for GxP applications such as LIMS, CTMS, MasterContol and other similarly classified IT R&D applications
Work closely with Clinical Apps Manager of IT & R&D Applications to lead initiatives to improve IT R&D effectiveness and efficiency
Responsible for maintaining the validated state of IT R&D applications to ensure compliance to regulatory standards
Leading a team of staff including programmers, analysts, and support specialists
Selection and procurement of appropriate hardware and software
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
Identify the priority of IT R&D support and project requests that impact the system
Knowledge of validation lifecycle of GxP computerized systems.
Ability to develop solutions to complex problems that require a high degree of ingenuity, creativity, and innovation within the boundaries of industry compliance regulation.
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
Guide IT R&D as Subject Matter Expert (SME) in the event of Regulatory Audits and Inspections
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.
Oversee R&D administration and operational support including user and security management.
Responsible for timely closure of IT R&D Exception Reports, CAPAs and Deviations
Responsible for review and approval of vendor agreements
Participate in troubleshooting, root cause analysis and impact assessment of R&D production computer applications
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 8 to 10 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 standards
- 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.