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  • Location: Wellesley
  • Salary: $$$ To be discussed. Fantastic benefits including 401K
  • Job Type:Permanent

Posted 26 days ago

  • Sector: IRT & Informatics
  • Contact: Alex Butcher
  • Contact Email: alex.butcher@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Start Date: 2021-03-26
  • Job Ref: V-46696
Our global, award winning client provides develops industry leading RTSM solutions for the clinical research industry. Providing employees with a fantastic culture and an innovative environment, they are truly an employer of choice.

The Validation Specialist will work with the Quality and Delivery teams to ensure validation activities and deliverables for study related projects are properly planned and documented, as well as provide quality oversight to ensure validation remains intact throughout a study’s lifecycle.

RESPONSIBILITIES:
• Develop Validation Plans and Reports.
• Review and approve test executions performed by the Software Test Analysts during validation activities
• Identify location and completeness of validation artifacts for reporting purposes.
• Ensure compliance to governing SOPs to verify changes are executed in compliance with approved change control procedures to maintain studies in a validated state
• Assist in the development and maintenance of validation related procedures and deliverables
• Assist the Process Quality Management group with the internal audit program.
• Assist in investigations and resolution for study related deviations and CAPAs.
• Assist in day-to-day scheduling of validation deliverables, where applicable.

REQUIRED EXPERIENCE
• The position requires a minimum of 2 years’ experience in the clinical research field, ideally in the RTSM/IRT services delivery and/or Quality Assurance.
• A BS/BA degree in life sciences, healthcare, computer science, business, communication or information technology field, or equivalent experience.
• Strong technical writing skills
• The ability to escalate in a professional manner
• Demonstrable resilience in prioritizing quality against aggressive time constraints
• Experience with IRT/RTSM and quality system tools a plus

Roles are available in Boston, MA and Portland, OR.