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Clinical Trial Operations Opportunities at PAREXEL

Clinical Trial Operations

initiation Clinical Site Manager

Job ID 47656BR Berlin, Land Berlin
PAREXEL has launched a new clinical operating model to drive effectiveness, reduce hand-offs and increase employee, client and site satisfaction. Within this model, the initiation Clinical Site Manager (iCSM) serves as the clinical sites’ direct point of contact during the study start-up period. The iCSM role offers the opportunity to go beyond the role of a typical clinical monitor. iCSMs are accountable for using their expertise to build and maintain the site relationship and ensure they are set up for success. iCSMs manage the sites during the start-up
period from site selection to site initiation.

Your Key Accountabilities:
  • Act as PAREXEL’s sole contact with assigned clinical sites
  • Use your trial management expertise to oversee the overall integrity of the study and problem-solving skills to promote positive working relationships with the site and staff
  • Review the performance of the trial at designated sites
  • Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines Ensure compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s)
  • Monitor completeness and quality of Regulatory Documentation and perform site document verification

Qualifications

  • Site Management experience or equivalent experience in clinical research, with the understanding of clinical trials methodology and terminology
  • University degree (biological science, pharmacy or other health-related disciplines)
  • Client focused approach to work; flexible attitude with respect to work assignments and new learning
  • Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply the understanding of study protocol(s)
  • Work ethically and honestly to promote the development of life-changing treatments for patients
  • Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word

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