Business Analyst (eSignature & eRecords)

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Job description

Required
- Bachelor's degree
- 4 years of BSA in related field
- 21 CFR Part 11 compliance experience (eRecords and eSignatures)
- Validation Lead for Product Implementations

Business Analyst

Our client has a brand-new position available that will play an integral part of their continued success! If you're a BA, with some serious experience in the clinical setting (21 CFR part 11), then this is the position for you; we want to hear from you!

A little about the opening:

The Business Analyst is responsible for assisting in the oversight and validation of Commercials off the Shelf (COTS) Products for our client. Reporting to the Business Relationship Manager, the Business Analyst will work in close partnership with product configuration teams, operations, and technical teams to facilitate the oversight and management of COTS products in a validated environment.

More info on your day-to-day:

• Gather specifications/requirements for, developing, and maintaining validation documentation for COTS products.
• Work independently to review requirements to create the changes required for implementation, as well as the oversight with the changes introduced.
• Under the guidance and direction of Business Operations leadership, support the implementation of new versions for validated COTS products.
• Align with current release schedule to ensure new versions are maintained and change management is executed based on PfM procedures.
• Conduct analysis and proactively identify key business insights to assist departmental decision making.
• Monitor system releases and plan for implementation.
• Works with the user community to define requirements for standard reports, and implements, tests and documents these reports,
• Provide Project management in support of key business initiatives.

Qualifications for the Role:

Minimum:

• Bachelor's degree in computer science or a related field.
• Minimum 4+ years' experience within Computer Systems Validation.
• 21 CFR Part 11 experience

Other Required:

• Validation Lead for Product Implementations
• Experience with commercial off the shelf product configuration and management.
• Experience in a GxP and GVP regulated environment.

Competencies:

• Ability to deliver on commitments
• Understanding of service culture
• Demonstrates a high degree of professionalism, as evidenced by ability to work remotely and independently, with the ability to drive tasks to completion within timelines.
• Positive interactions with customers and teammates, including good interpersonal skills.
• Strong Communication Skills, both verbally and written.
• Process-oriented, independent self-starter.
• Strong adaptability and capacity to work in fast-paced environments.
• Experience with Clinical Trial processes.
• Strong interpersonal and organizational skills

- provided by Dice