Clinical Review Specialist

Summarized Purpose:

Reviews patient data in accordance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs)/Working Practice Documents (WPDs) and Data Validation Manuals (DVMs). Clinical Review Specialists will be expected to liaise with colleagues in other functional groups as required, and to communicate with management for all data review activities within their allocated studies.

Essential Functions:

Reads and understands project protocols and Data Validation Manuals.Reviews patient data in accordance with the Manual Data Review Plan in the Data Validation Manuals (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.

Summarized Purpose:

Reviews patient data in accordance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs)/Working Practice Documents (WPDs) and Data Validation Manuals (DVMs). Clinical Review Specialists will be expected to liaise with colleagues in other functional groups as required, and to communicate with management for all data review activities within their allocated studies.

Essential Functions:

Reads and understands project protocols and Data Validation Manuals.Reviews patient data in accordance with the Manual Data Review Plan in the Data Validation Manuals (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:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) or equivalent combination of education, training, & experience.Knowledge, Skills and Abilities:Ability to effectively apply knowledge and skills in a highly organized fashion utilizing adherence to regulatory guidelines, SOPs and client expectationsExcellent understanding of pharmaceutical/clinical/medical terminologySkilled in interactive computer programsStrong customer focus and excellent interpersonal skillsProven flexibility and adaptability when working in a team and independently using good judgment in making decisionsEducation and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) or equivalent combination of education, training, & experience.Knowledge, Skills and Abilities:Ability to effectively apply knowledge and skills in a highly organized fashion utilizing adherence to regulatory guidelines, SOPs and client expectationsExcellent understanding of pharmaceutical/clinical/medical terminologySkilled in interactive computer programsStrong customer focus and excellent interpersonal skillsProven flexibility and adaptability when working in a team and independently using good judgment in making decisions