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 shift-based working hours.
Learn more about our EEO & Accommodations request here.
Skills Required
- University or college degree in life sciences, health sciences, information technology, or a related subject, or certification in an allied health profession
- Fluent written and verbal English
- 2–4 years of experience in clinical data management and EDC testing
- Hands-on expertise with Rave and Veeva
- Relevant and equivalent experience in lieu of educational requirements
- Attention to detail and a neat, methodical, thorough approach
- Ability to prioritize workload and meet demanding deadlines
- Effective communication and teamwork skills
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
