Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).
Coordinates the timely review of protocol inquiries, serious and non-serious adverse events and diagnostics; tracking all necessary data and generating reports for the client, project team and/or external vendors. Identifies and redacts subject identifiers per local requirements; retraining sites and advances reoccurrences to PPD Data Privacy. Compiles adjudication dossiers and creates/submits follow-up to investigative sites. Leads project specific training in collaboration with the project lead/manager, including the application of training within the learning management system. Performs data entry into tracking systems and performs system reconciliations to identify issues which may negativley impact project timelines. Coordinates and facilitates project and/or client meetings, drafts meeting minutes, posts to client portals and distributes to internal and external project teams. Leads the set-up, maintenance and archival of program files within PPD's electronic filing system. Liaises with various internal function groups to implement projects, ensuring contractual obligations are met and timelines are achieved. Answers incoming hotline calls, forwards information received at the Incoming Information Center (IIC) to the designated teams. Supports any specific activities performed by the local office, which cannot be performed from elsewhere.
Qualifications: Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
Working Conditions and Environment: Work is performed in an office environment with exposure to electrical office equipment Potential aims to site locations and/or travel required on rare occasion Majority of work computer-based Long varied hours required on occasion
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
EEO & Affirmative Action Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
