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Cra Line Manager

hace 3 meses

En remoto, España OPIS s.r.l. A tiempo completo
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 daytoday 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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