Regional CRA Manager
Pharmaceutical Company based in Buckinghamshire
Permanent- Office based
Our client is a leading pharmaceutical company, located in Buckinghamshire. Working across multiple therapy areas, they research and develop both ethical, consumer health and Medical device products in a range of therapy areas including dermatology, ophthalmology, neurology and other speciality markets.
CSL are privileged to have a longstanding relationship with this client and have made many placements both for permanent and contract openings so can really vouch for them when we say that candidate feedback is extremely positive and this is a great place to work.
Our client is looking to recruit a Regional CRA manager (International role) to manage vendor assigned (FSP) CRA Managers and to lead a small team of CRAs across Europe.
To manage FSP CRA Managers and to develop and motivate a small team of Clinical Research Associates to deliver on all clinical trial commitments in the geographic area assigned
To ensure the clinical monitoring work performed by the Clinical Research Associates is of the highest standards and studies are audit and inspection ready at all times.
Work with senior management within^clinical operations and study management to facilitate a strong collaboration
Work with FSP management in resource planing and resource allocation
With FSP management devise and implement budgets, metrics and training plans
Responsible for developing the resourcing plan, budget proposal for assigned region, and the monitoring plan
Issue escalation of findings related to the quality of and performance of site management and monitoring activities
Corrective and preventative action responses to site management-and monitoring-related observations on audits and inspections
Essential Skills & Qualifications Required
Degree in Life Sciences or related field.
Previous monitoring experience
Study management experience
Resource planning and recruitment experience
Experience with leading teams to database lock
Previously worked for a Pharmaceutical company or CRO
Direct line management experience
Good understanding of clinical study budgeting and the drug development process
20% travel required in this role
Employer: Pharmaceutical Company
Employment Type: Permanent
Hours: Full time
Location: Office Based in Buckinghamshire with 20% travel
Plan Start Date: Negotiable
Clinical Research, Clinical Operations, Clinical R&D, CRA, CTM, CTA, GCP, Site Manager, Monitor, Manager, Study Manager, EUCTD, ICH GCP, Project Manager, Clinical Study, Clinical Programme, Feasibility, Essential Documents, GCP, SOPs, Compliance, Training,Investigator Meeting, REC, Research Ethics. R&D, Trust, SMO, line Manager, Quality Control, QC
Assigned Consultant: Gabrielle Gainsborough at CSL on 01932 234682
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs, applicants will only receive feedback if they are suited to the role. The role may have been remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We are^unable to respond to applicants who are not EU nationals unless they include evidence of right to work in full time employment with their application. Do apply with relevant information on required location or salary/day rate if you are a new