Covance are seeking an experienced Clinical Research professional in the UK with a passion for 'Quality'.
This Pivotal Quality focused role partners with the UK & ROI GCTO clinical operations group to champion their adherence to key processes, systems and initiatives to ensure inspection readiness.
Would suit someone with a keen eye for detail and who has learnt and enjoyed the experience of being audited/inspected or has had high involvement in the SOP/writing review process and who would like to explore being in a role that plays a critical part in implementing and managing the roll-out of process/systems training of ongoing changes to regulations, guidelines, ICH-GCP standards and global processes.
Key attributes are to be able to drive and support the CAPA process and mitigate for quality issues in key high risk areas and ensuring best practices are shared across operations group and/or EMEA region. Needs to be confident communicating cross-functionally and at all levels and is comfortable being in a visible role where they are a key player in training and advising all clinical operations staff.
Responsibility for the annual country specific QC plan, monitoring, and coordinating the
implementation, and execution of QC plan in the respective country/US region according to the
Client Standard Operating Procedures and ICH Guidelines and GCP
Responsibility for the management of the Client Corrective and Preventive actions (CAPA) of
GCP audits and inspections in the country/US region at the Client level according to the Client
Standard Operating Procedures and ICH Guidelines and GCP
Responsibility for the annual country specific quality plan, monitoring, and coordinating the
implementation and execution of QC in the respective country/region
Responsibility to manage and/or co-lead key Client initiative charged with executing the
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ACCQM identifies local as well as global process improvement opportunities and training needs, and will be the local point of contact for all stakeholders ensuring appropriate training is implemented
The role requires the ability to follow current processes and procedures of the Client but also the ability to improve processes and procedures
This position has a significant impact on the ability to conduct clinical trials in accordance with external and internal regulations and guidelines of the Client
ICH Guidance and GCP Regulations, Country Client SOPs: Is an expert at local level.
Local Lead for Management of the Client Country Standard Operation Procedures
In cooperation with country functional area heads: ensures the Client CSOPs are checked /updated regularly; signs/authorizes CSOP deviations along with process owner.
Responsible for all aspects of the quality site management as prescribed in the project plans
Local Quality and Process Improvement and training contact person- identifies local training demand, initiate local training needs and activities.
Defines an annual country QC plan with collaboration to regional CQM
With mutual agreement with the functional areas will perform quality control (QC) activities and visits. Support on resolution of quality issues
Responsible for management and support audit preparation activities. In cooperation with country functional area person initiate state of the art root cause analysis for audit and inspection findings
Responsible for country trend analysis and impact assessments of audits and/or inspection findings
Candidates with the following experience will be suitable for consideration:
- Local regulatory experience
- Quality Management Systems
- Root Cause Analysis
- Experience of leading training sessions (and creating training materials)
- SoftSkills; Strong leadership
To apply, please contact Andy Smith @ firstname.lastname@example.orgEducation/Qualifications:
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
Thorough understanding of the drug development process
Fluent in local office language and in English, both written and verbal
Minimum of four-eight (4-6) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
Deep knowledge and understanding of Clinical Trial processes and quality management tools
Demonstrated experience leading cross-functional teams of business professional
Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results
Excellent site monitoring skills
Excellent study site management skills
Ability to work with minimal supervision
Good planning and organization skills
Good computer skills with good working knowledge of a range of computer packages
Excellent verbal and written communication skills
Ability to train junior staff
Ability to resolve project-related problems and prioritizes workload for self and team
Ability to work within a project team
Works efficiently and effectively in a matrix environment
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