CRA Training 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.
This is a newly created and challenging post, office based in Marlow. You^will be responsible for developing training and rolling this out to CRA's across the EU, and therefore need to be able to demonstrate strong leadership qualities. You must have demonstrable and recent background in carrying out training for monitors/CRA and have ideally monitored in the past. There is some UK/EU travel involved in the role but only about 10%.
CRA Training Manager deliverables include the following:
Assist the global Sr. Manager to develop and maintain global and local training materials repositories
Assist the global Sr. Manager to develop global processes and standards
Coordinate and provide on-boarding training for Our client's, FSP or CRO staff in local or global regions (NA, EU or APAC.
Collaborate with global^and regional stakeholders to identify training needs and work with the Global Sr. Manager to determine priorities and develop training strategy
Collaborate with partner departments and subject matter experts to ensure training remains current, compliant and relevant within the region
Provide ongoing training to department at regional meetings and web training. Regularly measure and evaluate effectiveness of training and delivery within the region and across regions
Conduct on-site visits with monitors within the region to provide process training as needed
Ensure training at the regional level is inspection ready.
Regularly update industry and company specific knowledge and training skills within region
MINIMUM REQUIREMENTS
Qualifications/Experience:
Bachelor's degree or equivalent.
Significant relevant clinical trial experience, including as lead CRA.
Previous experience developing and delivering training, preferably in a clinical research environment.
Previous experience as a Regional CRA in the pharmaceutical industry required.
Knowledge:
Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
Good understanding of clinical study operations and the drug development process
Good understanding of training strategies, techniques and tools
Knowledge of concepts of clinical research and drug development
SharePoint
General therapeutic area education and training