Senior Business Analyst - Clinical Data Lake

3 days ago

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Verista, Inc.

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computer system validation • CQV • QMS • automation engineering • R&D

501 - 1000

Description

•Verista’s 600 experts team up with life science brands to solve business needs •Empowering growth and innovation within the scientific community and addressing healthcare challenges •Company culture emphasizes empowerment, client success, courage, inclusivity and skill enhancement •Senior Business Analyst will manage clinical data requirements and support DevTech Products •Responsibilities include authoring documentation, support testing and compliance with regulatory requirements •Build relationships with stakeholders and drive project delivery independently

Requirements

•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 •Experience working with global teams remotely •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 •Solid understanding of Agile SDLC concepts with working knowledge of tools like JIRA and Confluence •Ability to articulate technical requirements in user stories for clinical data system implementations and integrations •Experience in gathering requirements for cloud-based applications, particularly on AWS •Proficiency in managing use case requirements, conducting knowledge transfers with developers and testers, and supporting UAT with stakeholders •Knowledge of Quality Process Assurance/Compliance, 21 CFR Part 11, GxP regulations, and validation procedures

Benefits

•High growth potential and fast-paced organization with a people-focused culture •Competitive pay plus performance-based incentive programs •Company-paid Life, Short-Term, and Long-Term Disability Insurance. •Medical, Dental & Vision insurances •FSA, DCARE, Commuter Benefits •Supplemental Life, Hospital, Critical Illness and Legal Insurance •Health Savings Account •401(k) Retirement Plan (Employer Matching benefit) •Paid Time Off (Rollover Option) and Holidays •As Needed Sick Time •Tuition Reimbursement •Team Social Activities (We have fun!) •Employee Recognition •Employee Referral Program •Paid Parental Leave and Bereavement