Clinical Research Associate Team Manager
hace 4 días
Job Overview
IQVIA is seeking an experienced Clinical Research Associate Team Manager to join our team.
Key Responsibilities:
- Manage and coordinate the efforts of cross-functional project teams to support milestone achievement and manage study issues and obstacles.
- Develop study management plans, including team assignments and accountabilities, and oversee database maintenance.
- Serve as primary project contact with sponsors to ensure communication is maintained and reporting schedules are adhered to.
- Collect information on team performance against contract, customer expectations, and project baselines.
- Lead problem-solving and resolution efforts, including management of risk, contingencies, and issues.
- Identify quality issues within studies and implement corrective action plans, escalating findings and action plans to appropriate parties.
- Provide input to line managers on the performance of their project team members relative to project tasks.
- Prepare and present project information at internal and external meetings.
- Participate in proposal development and bid-defense processes under guidance and supervision.
- Ensure high performance and efficiency of clinical teams through scheduling co-monitoring/accompanied site visits and ongoing mentoring of CRA team members.
Requirements:
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- At least 3 years of on-site monitoring experience.
- Equivalent combination of education, training, and experience may be accepted in lieu of degree.
- In-depth knowledge of and skill in applying applicable clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Strong therapeutic and protocol knowledge as provided in company training.
- Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint, and use of laptop computers and mobile devices.
- Written and verbal communication skills, including a good command of the English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
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