PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 44 countries and more than 11,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit Clinical Review SpecialistThe objective of a Clinical Review Specialist is to review patient data in accordance with Good Clinical Practice, Standard Operating Procedures/Working Practice Documents 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. Duties and Responsibilities (according to relevant guidelines, laws and SOP's) • Reviews patient data in accordance with the Manual Data Review Plan in the DVM.• Uses medical knowledge to clarify and resolve issues with clinical data (e.g. adverse events, concomitant medications, concurrent medical conditions etc.) gathered during lifecycle of clinical trials.• Identifies potential 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. • To ensure that all work conducted is completed to the acceptable quality in accordance with SOPs/WPDs, Protocol and DVM.• To ensure all required documentation, as defined in the SOPs/WPDs and DVM, is created and filed correctly. QualificationsLife Science Degree (and/or relevant qualification/experience) Valid drivers license (where applicable) and passport Ability to effectively apply knowledge and skills in a highly organized fashion utilizing adherence to regulatory guidelines, SOPs and client expectations Knowledge of medical and/or clinical trials terminology Experience that demonstrates strong attention to detail and skill with numbers Effective oral and written communication skills Good organizational and analytical problem-solving skills Ability to work well under pressure Professional ability to deal with individuals from all levels Ability to work productively with minimal supervision Strong customer focus and excellent interpersonal skills Proven flexibility and adaptability Ability to work in a team environment and independently as required Must demonstrate good judgment in making decisions Ability to set and work to timelines and able to effectively negotiate timeline changes if necessity demands Strong command of English language and grammar Willingness to travel to other locations as required or as business need dictates A minimum of three years relevant experience in a clinical research environment with a minimum of 1 year experience reviewing and validating clinical or medical data. Related experience would be taken into account. Knowledge of Oracle Clinical would be an advantage.
If you think that you have the right qualifications and wish to be part of our global team, please apply online by sending your CV in English.