Established in 1982, Chiltern is a leading global Contract Research Organization with extensive experience of in conducting and staffing global Phase I to Phase IV clinical trials across a broad therapeutic range.
We provide product development services to the pharmaceutical, biotech and device industries including Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions.
By understanding our customer’s needs for timely and accurate results we aim to exceed rather than simply meet their expectations. Our commitment to quality and service-led relationships is evident in our high rate of repeat and referral business and in our high levels of staff retention.
For assignment to our client a leading pharmaceutical company, we are looking for an Unblinded Regional Site Manager (CRA / Senior CRA) to manage sites in Poland, Bulgaria and possibly some travel to Ukraine and Russia, candidates will be employed by Chiltern part of a Covance company to provide their services to our client.
The successful candidate will be fully dedicated to our client studies and integrated into their Clinical Site Management and Monitoring Department.
As required to provide country and study support to studies including involvement in, but not limited to the full coordination and management of site activities:
ethics support / handovers
site set-up (qualification visits, initiation visits)
site management (contact between on-site visits)
Where appropriate, and required by local customs regulations, the RSM may assist in the importation / exportation of study supplies including Investigational Product.
The RSM role deliverables include, but are not limited to, the following:
Completed site-level feasibility tool/questionnaire
Monitoring Plan compliance
Clinical site visit reports within metric timelines
List of qualified sites following feasibility conduct (shared deliverable)
Site specific patient recruitment and retention plans (shared deliverable)
Collection of high-quality clinical trial data (CRFs)
Query and Issues resolution
Corrective and preventative action responses to monitoring-related observations on audits and inspections
Response to requests for site level study and/or territory information
Learning management system(s) compliance
Experience and knowledge required;
Candidates should ideally have at least 3 years CRA experience
Must be able to communicate effectively in the English language.
Experience of monitoring CNS and GI Studies would be an advantage although not essential.
Good understanding of Good Clinical Practices, ICH guidelines, ethics, patient privacy laws, EU Directive and other applicable local regulations
Should live near main airports/transport links
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
Ability to handle and prioritise multiple therapeutic areas and projects simultaneously
Self-starter with ability to work independently in a regional area with remote or minimal supervision
Ability to work effectively in a team/matrix environment
Ability to influence others without direct reporting relationships
Ability to understand technical, scientific and medical information
Advanced computer skills (word processing, spreadsheets, graphics, presentation slides, electronic data capture
We are ideally looking for someone to start in December.
To apply for this position or for more information about this role please contact Nicky Cooke on + 44 1256 818323 or email firstname.lastname@example.org
Please note that if your experience does not mirror that of the requirements for this role you may not receive a response.
Candidates must be eligible to work Poland.