Lead Clinical Research Associate

Job Overview

Lead CRAs will be assigned to different studies conducted in one or more countries to deliver and progress the assigned studies.

Essential Functions

•    Clinical dedicated team
•    To work closely with CRAs in Korea and other APAC countries, overseeing and coordinating site management activities.
•    To oversee the overall study monitoring plan compliance for the studies and countries assigned.
•    To serve as primary point of contact for IQVIA CRAs and CPMs for any study monitoring related questions or concerns.
•    To provide oversight of site monitoring data management activities (entails pulling data management reports and leading the follow-up on missing pages, outstanding queries etc.)
•    To review Monitoring Visit Reports and advise CRAs on any study related questions.
•    To prepare, lead and follow up regular meetings (frequency to be determined by CPM and Lead CRA for each of the studies) with the CRA and CPM to review study status, risks, trends, upcoming data timelines etc.
•    To collaborate and liaise with CPM for project execution support as appropriate.
•    To support CRA with study issue resolution.
•    To report any staff performance concern to the Line Manager.

Qualifications
• Bachelor's Degree Degree in scientific discipline or health care preferred.
• This position is an opportunity open to current Senior CRAs seeking career growth

• Good English communication skill is required

• Good knowledge of and skill in applying, applicable clinical research regulatory requirements.
• Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com