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 and consumer health products in a range of therapy areas including dermatology, ophthalmology, neurology, medical devices 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 lead a team of CRAs across Eastern Europe.
To lead, manage, develop and motivate Clinical Research Associates to deliver on all clinical trial commitments in the geographic area assigned
To ensure the overall quality of the^site management and monitoring work performed by the Clinical Research Associates
To provide a single point of contact for the TA Teams and other stakeholders for the region
To align execution activities with agreed-upon project priorities, timelines, quality/productivity specification, in compliance with GCP and local laws and regulations governing the conduct of clinical research
To act as an extension of, and whenever appropriate a surrogate in the field for, the TA study teams and other^Development operational functions
Responsibility 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
Authors strategic plan to develop territory and responds to requests for regional level study and/or territory information
Performance appraisal of direct reports
Essential Skills & Qualifications Required
Degree in Life Sciences or related field.
Clinical study site monitoring and/or site management experience, both in-house and outsourced.
Above^to have been gained across multiple countries including newer European member states.
Previous experience in the biopharmaceutical industry and/or early Phase experience advantageous.
Direct line and indirect people management experience - multinational desirable.
Good understanding of Good Clinical Practices e.g.: ICH guidelines, PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations, when country-based
Good understanding of clinical study budgeting and the drug development process
Knowledge of concepts of clinical research and drug development
General therapeutic area education and training
25- 50% travel required in this role
Employment Type: Permanent
Hours: Full time
Location: Office Based in Buckinghamshire with 25-50% 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, Site 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