CRA (iCRA) CRA( ) CRA iCRA / (CRA)ICF CTMS, e TMF ,SOP, ,SOP, iCRAiCRA (CRA)5() TOEIC 700Reading & Writing

Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what w

An exciting opportunity for Facilities Coordinator to join the Corporate Real Estate & Services (CRES) team. Do you have experience of working within a CRES services environment, excellent communication skills together with a professional customer service approach then we would like to hear from you! This position will be based a t Parexel's Harrow Unit (located in Northw

An exciting opportunity for Laboratory Assistant (bank) to join the Early Phase team based at Parexel's Clinical Unit in Harrow (located in Northwick Park hospital). Do you have practical laboratory experience in the pharmaceutical industry and/or research institute? Are you practical and dexterous? Then we would like to hear from you! As a Laboratory Assistant you will c

Senior Regulatory Affairs Associate must understand the organization's consulting models and methodologies, as well having as good knowledge of what services PC provides. The Senior Regulatory Affairs Associate must have good technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization ensures the ti

Parexelstrives to be the premier provider to the biopharmaceutical and medical device industries for the development and commercialization of new medical therapies worldwide. Our mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the biopharmaceutical and medical device industries in preventing and curing dis

Support the continuous improvement of key components of the Quality Management System (QMS) and related standards. Work with QMSO leadership to assess and report on the functioning of components constituting the QMS. Supporting Activities QMSO Support As assigned, complete QMSO goals for the key QMS elements. Maintain a familiarity with Parexel QMS related applications an

Key Accountabilities Deliver best value and high quality service. Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH GCP and/or other international regulatory requirements are performed. Assist in the coordination of pro

Demonstrates full competence when conducting the following tasks Development of database build specifications Development of data validation specifications Test data creation & UAT Performing/ leading functional QC activities and testing Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc. Data validation and cleaning Conduct medical coding if assig

GCP(Good Clinical Practice) SOP(Standard Operating Procedure) SDV Source Data Verification) CRF Case Report Form) IRB (Institutional Review Board) Job Qualifications CRA 1 Web Web

More about you On your first day we'll expect you to have Experience Experience in Statistics and its applications to clinical trials or observational studies, in industry or course work Prior experience with SAS or R programming desirable Education A Masters or Ph.D. level education in biostatistics, statistics, mathematics, or another relevant discipline (preferred) Ski

What you'll do Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports. Build relationships. Oversee integrity of the study and utilize problem solving skills to promote rapport with the site and staff. Protect patients. Review

The main responsibility of the Site Contract Leader is the negotiation of study specific, generic, site specific and country Clinical Site Agreements (CSA) and any other agreement that is required for the completion of the Site Initiation Visit (SIV). The Site Contract Leader is also responsible for managing CSA activities and liaising with study specific stakeholders to

FSP (Function Service Provision)CROCRO CRA 1

CRA 1 Key Accountabilities Start up (from site identification through pre initiation) Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start up phase. Build relationships with investigators and site staff. Conduct, drive and manage country specific feasibility and/or site pre qualification and qualification acti