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

We are now looking for a Contracts Specialist to be based in Romania (the role can be based in our office in Bucharest or home based anywhere in Romania). In this role, you will amend, negotiate and finalise project budgets together with creating draft contractual documents. You will have the opportunity to work closely with colleagues across various departments such as F

Provide a range of leadership and influencing capabilities to achieve the business objectives and goals for both Parexel and clients Effectively communicate with internal and external customers as well as third party vendors Participate in cross functional meetings and support initiatives to ensure the delivery of milestones and timelines for clinical trials Ensure all sy

We are looking for a Senior Regulator y Affairs Associate to join our growing team in Romania. This role can be either home or office based in Bucharest. As a Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in Clinical Trail Applications (CTA) from various European locati

The Senior Initiation Clinical Research Associate ( Sr iCRA ) specialises in performing all study start up activities for a clinical trial. You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The Sr iCRA can also support protocol amendments if applicable. This role in

Manage Projects & Technology Lead and implement the setup of Data Receipt Agreements with vendors by working with cross functional teams. Programming and setup of Import procedures to allow the ingestion of data either using SAS or alternative technology (e.g. "Workbench") Programming of reconciliation checks to ensure appropriate transfer of data. Programming of offline