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Clinical Site Manager II / CRA II

Employer
Parexel
Location
Paris, France
Salary
Competitive
Start date
17 Oct 2019
Closing date
16 Nov 2019

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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 Clinical Site Manager (CSM), formerly the Clinical Research Associate (CRA), serves as the clinical sites' direct point of contact. The CSM role offers the opportunity to go beyond the role of a typical clinical monitor. CSMs are accountable for using their expertise to build and maintain the site relationship and ensure they are set up for success. This includes addressing and resolving site issues and questions. You will also manage site quality and delivery from site identification through to close-out.

As a CSM, PAREXEL will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers. Your hard work will be rewarded through a bonus incentive program, the opportunity to work within multiple therapeutic areas, and an opportunity to advance your career in clinical research. If impact, flexibility, and career development appeal to you, please apply to learn more.

Your Key Accountabilities:
  • Act as PAREXEL's sole contact with assigned clinical sites
  • Use your trial management expertise to oversee overall integrity of the study and problem-solving skills to promote positive working relationships with the site and staff
  • Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites; generate visit/contact report
  • Review the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are protected and are in accordance with protocol
  • Evaluate the quality and integrity of the reported data, site efficacy, and drug accountability
  • 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

Your Skillset:
  • Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
  • Educated to degree level (biological science, pharmacy or other health related discipline)
  • Demonstrates strong interpersonal, written, and verbal communication skills within a matrixed team
  • Ability to work in a self-driven capacity, with a sense of urgency and limited need for oversight
  • 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 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
Our Offer:

Join the best minds in the industry and leverage your expertise to help advance treatments into the hands of those who need them most. This role is an excellent opportunity to enhance your skills and take the lead on client projects.

We look forward to speaking with you and determining how PAREXEL fits into your career journey!

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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