Job... Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health...
PURPOSE
Assist in the execution of the assigned regionally-based clinical study(ies) per Contract, from initiation through to closeout. Support all clinical study related activities for assigned projects in accordance with SOPs, policies and practices, meeting quality and timeline metrics.
RESPONSIBILITIES
- Clinical Monitoring Activities (on-site and remote monitoring visits)
- Create, track and report on project timelines.
- Produce and distribute status, tracking and financial reports for internal and external team members and senior management.
- Assist the clinical project manager(s) with budget allocation and approval of invoices
- Serve as primary back up project contact with Sponsor and internal project team to ensure communication is maintained and reporting schedules are adhered to.
- Escalate findings and action plans to appropriate parties.
- Coordinate data gathering for the development of proposals for new work.
- Prepare and present project information at internal and external meetings.
- Coordinate with other project support staff within and outside the Clinical Project Management Unit to identify and consolidate support processes.
- Train and may coordinate the work of more junior project support staff.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Understanding of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- Basic therapeutic and protocol knowledge
- Strong communication and interpersonal skills, including good command of English language
- Good problem solving skills
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics
- Excellent customer service skills
- Ability to work under limited direction
- Strong software and computer skills, including MS Office applications
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in life sciences
- 5 years’ clinical research experience as CRA
- Project Management or lead experience would be an advantage
- English and Spanish Fluency
Whatever your career goals, we are here to ensure you get there!
We invite you to join IQVIA™.
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