Job Description

• Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. If applicable, Clinical Research Associates may be accountable for development of project subject recruitment plan on a per site basis. Support work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Build awareness of features and opportunities of study to site.
• Collaborate and liaise with study team members for project execution support as appropriate.

IQVIA Malaysia offers a broad array of integrated information and technology-enabled services and solutions to help its clients improve their clinical, scientific and commercial results. We have more than 30 years\' experience in Malaysia and understand the country\'s biopharmaceutical and healthcare markets.

Established in the 1980s, IQVIA Malaysia has one of the most comprehensive offering portfolios in the region. We offer a full spectrum of clinical and commercial solutions for biopharmaceutical, medical device and other healthcare clients.
We have a strong history of innovation to meet client needs. Two of our 11 Prime Sites in Asia Pacific are in Malaysia. Prime Sites are major leading institutions with access to large numbers of patients and broad therapeutic expertise.
Bachelor\'s or Equivalent