Research Site Manager

2 weeks ago


Petaling Jaya, Selangor, Malaysia Merck Gruppe - MSD Sharp & Dohme Full time

**Job Overview**

We are seeking a highly motivated and experienced Clinical Research Associate (CRA) to join our team in Malaysia. As a CRA, you will play a critical role in ensuring the success of clinical research studies at assigned sites.

Our company has been recognized as one of the Best Companies to Work for in 2019 by HR Asia, and we are committed to providing a supportive and inclusive work environment for our employees.

The successful candidate will have a strong understanding of clinical research, good documentation practices, and effective communication skills. They will be responsible for developing strong site relationships and ensuring continuity of site relationships through all phases of the trial.

Key responsibilities include:

  • Performing clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
  • Coordinating & managing various tasks in collaboration with other sponsor roles to achieve Site Ready.
  • Participating & providing inputs on site selection and validation activities.
  • Communicating with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

You will also be required to work independently across multiple protocols, sites and therapy areas, with a high sense of accountability / urgency and ability to set priorities and handle multiple tasks simultaneously in a changing environment.



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