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.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Fluent in English, both written and verbal.
Experience (Minimum Required):
3 years of validation experience working with a global CRO/Pharma
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.
Flexibility – being able to move from one computer system to another with ease and adapt to modern technology and a constantly changing work environment.
Physical Demands/Work Environment:
Home based
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