Our client is a mid-size CRO that has a massive global reach and strives to deliver cost-effective, quick-to-market clinical services in today's emerging marketplace. They have a vacancy for a CRA Line Manager to join their team in Madrid, Spain.
The Clinical Research Manager (CRM) will provide leadership, mentorship; training and career development for assigned Clinical Research Associates (CRAs) and/or Project Managers (PMs) to assure the objectives of the company and the sponsor are met. The CRM will provide guidance to ensure that staff fulfils responsibilities, to the company and the client, in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies.
Support the Clinical Operations Manager with the day-to-day functional and organizational activities of Clinical Research Associate (CRA) management.
Responsibilities will include:
- Assists the Clinical Operations Manager in resourcing CRAs and/or Project Managers (PM).
- Provides leadership, mentorship and career development for the assigned staff, including monitoring performance and identifying training needs.
- Oversees and manages the assigned CRA workload.
- Assist CRAs in managing time and tasks to adhere to study budget and timelines.
- Provide guidance to ensure that staff fulfils responsibilities, to the company and the client, in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies.
- Liaises with project management to ensure CRAs are fulfilling monitoring requirements and meeting project and client timelines; attends assigned project team calls as needed to support the clinical deliverables of the project, and CRA or LCRA/CTL project team member transition meetings.
- Reviews the budgeted and recorded hours to ensure they are within acceptable working limits for active studies for the assigned CRAs.
- Participates in the interviews of candidates and hiring of new CRAs.
- Performs co-monitoring and monitoring duties as required.
- Plans and executes CRA training meetings, as well as contributes to and delivers CRA training curriculum.
- Contributes to the process improvement initiatives.
- Conducts CRA assessment visits.
- At least 7 years clinical research experience
- Bachelor or higher university degree in life sciences, nursing or medical background preferred
- Experience in a leadership capacity or line management
- Effective clinical monitoring skills
- Ability to establish and maintain effective working relationships with co-workers, managers, direct reports, internal and external clients
- Available for domestic and international travel, including overnight stays up to approximately 20% of the working week
- Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology
- Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.