Clinical Business Systems Analyst

Zifo is growing! We are looking for a Senior Business Analyst with 7+ years of experience in managing clinical data requirements, will be responsible for planning, business requirement/user story development. He /She will act as a primary subject matter expert for support for teams using assigned Product i.e. Clinical Data Lake.

Requirements

Functional Requirements:

• Author and refine system support processes, operational procedure documents (SOPs), flow diagrams, configurations, and interdependencies.
•  Author product release notes and communications for end users/ business stakeholders.
• Partner with Testing team to draft and review UAT (User Acceptance Testing) scripts and manage end to end UAT process until product release closure.
• Effectively translates business requirements into user stories and supporting documents like detailed requirement specifications, data mapping (STTMs) for the agile development team.
• Support product owner by aligning with business system owner for prioritizing the product backlog.
• Participate in the demand management process to assist the business in establishing business cases relating to new systems or potential system changes.
• Complete upgrades and enhancements to existing applications.
• Ensure compliance with regulatory requirements/controls related to business systems and IT infrastructure.
• Independently deliver projects and initiatives in a timely and qualitative manor.
• Highlight potential risks and act proactively to resolve issues.
• Follow company and departmental policies, procedures and ensure documentation according to the Quality Management Systems (QMS), Software Development Life Cycle, and Project Life Cycle standards.
• Work independently with stakeholders to prioritize requirements and is a primary resource on complex issues within a clear framework of accountability.
• Establish relationships with colleagues and analyze issues and guide the development of solutions within ongoing processes.
• Build and maintain relationships with key business stakeholders.
• Experience working in R&D and/or Biotech preferred.
• Working knowledge of clinical data systems such EDC, Clinical Data Management systems, eCOA, IRT, Statistical Analysis Environments, CTMS, and eTMF
  

Technical Requirements

• Bachelor's degree or equivalent in a science discipline or related field.
• 7-10 years of pharmaceutical industry or related experience in implementing Clinical solutions.
• Working Knowledge of managing requirements for AWS Cloud solutions and related services in Clinical data space.
• Proficient knowledge of Quality process Assurance/Compliance,21 CFR Part 11, and other regulations (GXP) required.
• Proficient in working within an SDLC framework (Delivery, Testing, Software Quality Assurance, Change Management).
• Hands on Agile tools like Atlassian Suite (JIRA/Confluence).
• Ability to articulate complex technical problems and solutions to a wide business audience and communicate solution value.
• Familiarity with change control and SDLC associated with computer system validation processes.
  

A successful Zifo-ite is:

• Independent, Self-Motivated & Results driven
• Willing & able to quickly acquire new Technical Skills & Business Principles
• A critical thinker who possesses logical reasoning
• Curious and always looking for creative solutions to complex problems

Benefits

CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 7 of the Top 10 Biopharma companies.

We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a “no doors” policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability.

We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.

If you share these sentiments and are prepared for the atypical, then Zifo is your calling!

Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.