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Associate Validator II

Role overview

Qualifications

  • University / college degree in life sciences, health sciences, information technology or related subjects
  • Certification in allied health professions from an appropriate accredited institution
  • Fluent in English, both written and verbal
  • 2–4 years of experience in CDM and EDC testing

Responsibilities

  • Serve as a member of the project team with primary responsibilities for all documentation requirements
  • Assist project teams with validation tasks as requested
  • Assist with creation, production, printing and tracking of study documents
  • Create and execute validation test scripts as requested and document the test results

Key facts

  • Remote from: India
  • Full time
  • Mid-level (2-5 years)
  • English

Hard skills

Other skills

  • Detail Oriented
  • Self-Motivation
  • Teamwork

About the company

Fortrea logo

Fortrea

Contract Research Organizations (CRO)

We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. As we tackle challenges in today’s world, we know that we need to be nimble and agile. That’s why we work side-by-side with our partners to eliminate inefficiencies from the process so we can help them deliver life-changing therapies faster for patients, caregivers and healthcare providers worldwide.

Company details

Company typeXLarge
IndustryContract Research Organizations (CRO)
Company size10001

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Job description

Job Overview:

Serve as a member of the project team with primary responsibility for all documentation requirements in support of Global EDC Solutions tasks to include receiving and logging-in and scanning contractual and validation documentation. Assist project teams with validation tasks as requested, i.e., with the creation, production, printing and tracking of study documentation and controlled documents.

Summary of Responsibilities:

  • Serves as a member of the project team with primary responsibilities for all documentation, requirements to support global EDC solutions tasks.
  • Assist project teams with validation tasks as requested.
  • Assist with creation, production, printing and tracking of study documents and other controlled documents as needed.
  • Create and Execute validation test scripts as requested and document the test results.
  • Ensure quality of work.
  • Prioritize workload to meet specified completion dates.
  • Assist with the maintenance of validation metrics.
  • Carry out all activities according to Fortrea Standard Operation Procedures (SOPs) and project specific conventions within the framework of Quality Management and Good Clinical Practice (GCP)/ICH guidelines.
  • Maintain accurate records of all work performed.
  • Perform other duties as assigned by management.
  • Assist with special projects as designated.
  • And all other duties as needed or assigned.

Qualifications (Minimum Required):

  • University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.
  • Fluent in English, both written and verbal.

Experience (Minimum Required):

  • 2–4 years of experience in CDM and EDC testing, with hands-on expertise in Rave and Veeva.
  • A neat, methodical, and thorough approach to the work with an emphasis on attention to detail.
  • Good concentration skills are required to meet the consistently high standards expected.
  • Self-motivation with the ability to work under pressure to meet demanding deadlines.
  • Effective communication skills and the ability to work as part of a team.

Preferred Qualifications Include:

  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Physical Demands/Work Environment:

  • Remote-Based, as requested by the line manager
  • Work Timings: Should be flexible to accommodate general or UK working hours.

Learn more about our EEO & Accommodations request here.

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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