Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Clinical Review Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to review patient data with a high level of accuracy. As a Clinical Review Specialist, you'll ensure that all tasks are conducted in accordance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs)/Working Practice Documents (WPDs), and Data Validation Manuals (DVMs). You will liaise with colleagues in other functional groups as required and communicate with management for all data review activities within your allocated studies.
What You’ll Do:
• Reads and understands project protocols and Data Validation Manuals.
• Reviews patient data in accordance with the Manual Data Review Plan in the DVM.
• Identifies data issues and works with PPD team and study sites to resolve.
• Ensures applicable data review activities are conducted accurately, and all related deliverables are completed to quality expectations, within budget and on time.
• Provides support, guidance and direction on clinical data review to the CDM project team
Education and Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• Ability to effectively apply knowledge and skills in a highly organized fashion utilizing adherence to regulatory guidelines, SOPs and client expectations
• Excellent understanding of pharmaceutical/clinical/medical terminology
• Skilled in interactive computer programs
• Strong customer focus and excellent interpersonal skills
• Proven flexibility and adaptability when working in a team and independently using good judgment in making decisions
Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.
• Night and weekend hours required based on project demands.