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

CRO GCP SOP SDV) IRB 4 / MR/CRC//// 202381

Due to a growing portfolio, we are currently looking for Project Quality and Risk Leads to be based in Serbia, Croatia or Turkey with flexible working hours. The Project Quality and Risk Lead assumes the lead (with support of LM or Mentor) of Quality oversight responsibility and partners with operational delivery teams focusing on first time quality, robust risk and issue

An exciting opportunity for Facilities Coordinator to join the Corporate Real Estate & Services (CRES) team. Do you have experience of working within a building 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 at Parexel's Early Phase Unit in Berlin.

of the Role The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data. In addition, the Senior Statis

1. Should have experience in eCTD, NeeS and paper formats. 2. Working experience in all major emerging countries (EU, GCC, US, ASEAN etc.) 3. Compilation, publishing, and technical quality control of Regulatory submissions including technical troubleshooting to ensure issues with submissions are resolved and deadlines met. 4.Should have experience in handling submission g

1. monthly closing for China statutory book 2. monthly quarterly tax filing related work 3. investigator drop file upload 4. account reconciliations 5. Statutory audit work