5711 - IT CSV Analyst (R&D) / Lead Validation Engineer

ZipRecruiter; Boston (MA); On-site; USD 87,000 - 146,000; Full time

Job summary

A leading company in life sciences seeks an IT CSV Analyst (R&D) in Boston. The role focuses on leveraging strong business analysis capabilities to drive IT system implementations in the R&D sector, requiring significant industry experience and knowledge of various R&D systems.

Benefits

401(k) Retirement Plan (Employer Matching benefit)

Medical, Dental & Vision insurances

Paid Time Off (Rollover Option) and Holidays

Tuition Reimbursement

Employee Recognition

Competitive pay plus performance-based incentives

Qualifications

• 10+ years of direct relevant industry experience.
• Strong BA capabilities, experience with SDLC and system configurations.
• Gene Therapy experience is a must.

Responsibilities

• Drive R&D IT system implementations.
• Transition from CSV to CSA approach for systems.
• Implement and validate lab informatics.

Skills

Communication

Critical Thinking

Problem Solving

Job description

Job DescriptionJob Description

Description

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

IT CSV Analyst (R&D) Responsibilities:

• Utilize strong BA capabilities and experience with SDLC, system configurations & testing strategies to drive R&D IT system implementations
• Transition from a CSV to CSA approach for software and/or non-instrument related systems
• Lab informatics implementation/validation
• Critical thinking and strategic planning for various validation approaches
• Problem solving in an R&D/regulated environment

Requirements:

• 10+ years of direct relevant industry experience
• Must have sound CSV knowledge/technical experience working with the following R&D systems (or similar): Veeva (Quality, RIM, CTMS & Safety), EDC, Shiny apps, Tracelink, Oracle fusion, Pinnacle SAS, GLAMS/AMS
• Must have Gene Therapy experience
• Must have strong BA capabilities as well as experience with SDLC and system configuration & testing strategies
• Experience with LabVantage (Implementation/Validation/Integrations) highly
• Experience with Veeva connector projects and appropriate validation approaches
• Knowledge of Veeva security profiles, configurations, reference lookups, DACs
• Strong communication and critical thinking skills

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

(US) Range$87,780—$145,307 USD

Benefits

Why Choose Verista?

• 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 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

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For more information about our company, please visit us at Verista.com