Cra Line Manager
hace 3 semanas
OPIS is looking for a skilled and experienced CRA Line Manager in EU. This is a remote, home-based role in Spain.
The Clinical Research Line Manager provides leadership and supports the Clinical Research Associate (CRA) team in executing clinical trials at a local and global level ensuring client projects are delivered efficiently, with high-quality and in compliance with the contract’s requirements.
**Some of what you'll do**:
- Coordinate, and oversee day-to-day activities of the CRAs ensuring the highest performance, quality and efficiency
- Ensuring effective CRA allocation, project specific training and overall smooth execution of CRA activities in relation to the agreed KPIs
- Assists the CRAs in issues resolution and proper escalation, ensuring that the corrective action plan is put in place within the agreed timeframes
- Plan and hold regular meetings with CRAs, accompany them on site visits, perform TMF checks and review monitoring visit reports
- Ensure a proper and timely handover in case of CRA change
- Identify any team performance issue and define the corrective action plan
- Ensure that Sponsor’s system are updated by the team within the required timelines
- Ensure that documents and correspondence are properly archived and Trial Master File is inspection ready
- Maintains contacts with the Sponsor and participate to meetings and teleconferences
- Collaborate in maintaining the SOPs related to his/her area of activity
- Perform monitoring activities for sites allocated to him/her, if needed
- Collaborate with the other Colleagues involved in the projects to ensure management of the full project lifecycle in compliance with regulations, quality standards, procedures and policies
- Motivate the team and encourage team members to be proactive, increase efficiency, take initiatives and share concerns
- Cooperate to hire and train new associates and act as a mentor for junior staff
**Requirements**:
- Enthusiasm, knowledge and proactivity
- Degree in a scientific field
- At least 5 years in clinical research field with proven line management experience
- Excellent knowledge of GCP
- Able to coordinate all the activities related to the site management and monitoring of clinical trials both local and international
- Effective interpersonal skills with excellent customer service and team leadership skills
- Excellent knowledge of English language
- Good ability to interact with colleagues and clients
We offer a competitive salary with other benefits and opportunity to develop your professional career with a growing company.
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