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Sr Clin Review Spec

The objective of a Senior Clinical Review Specialist is to review 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. Responsibilities may include, but are not limited to: 
  • Reads and understands project protocols and Data Validation Manuals (DVM)
  • Reviews patient data in accordance with the Clinical Listings Review Plan in the DVM
  • Identifies data issues and works with PPD team and study sites to resolve
  • Ensures data accuracy according to departmental operating procedures
  • 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 including consultation related to Listing Review and related sections of the DVM
  • Provides clinical review training to all CDM staff performing clinical review activities
  • Participates in the development and implementation of processes, procedures and training for the data management function, as directed
Education and Experience:Bachelor's degree or certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)Minimum of 5 years experience in a clinical research environmentMinimum of 3 years experience reviewing and validating medical dataIn some cases, a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily Knowledge, Skills and Abilities:Ability to effectively apply knowledge and skills in a highly organized fashion utilizing adherence to regulatory guidelines, Standard Operating Procedures and client expectationsExcellent understanding of pharmaceutical/clinical/medical terminologyExperience that demonstrates strong attention to detailExperience with interactive computer programsExcellent written and verbal communication skillsExcellent organizational and analytical problem-solving skillsAbility to work productively without direct supervisionHigh degree of confidentiality with medical records and client's proprietary dataDemonstrated working knowledge of Good Clinical Practices and applicable Standard Operating ProceduresExcellent customer focus and excellent interpersonal skillsProven flexibility and adaptabilityAbility to work in a team environment and independently as neededMust demonstrate good judgment in making decisionsMust be able to set timelines and commit to them or be able to negotiate schedule changes in response to project demandsAbility to travel to other locations as required or as business need dictatesStrong command of English language and grammarPharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

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