PAREXEL looking for Clinical Site Manager

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world.

Post : Clinical Site Manager II / CRA II

Job Description
• 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

Candidate Profile
• 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

Additional Information:
Location: India
Education: M.Pharm, M.Sc, B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CRA
End Date: 20^th January, 2019