GCP Compliance, Senior Manager, EU
Headcount role leading quality innovation in Clinical R&D. A role bridging GCP operations, CQA, Training and Inspection Readiness
Job Summary
A senior management role operating within a global environment, a^chance to maintain competitive edge for our clients business in terms of compliance by refining process, enhancing practice and ensuring quality and consistency with global peers. A pivotal position which also provides guidance and training in regulatory inspection readiness and supports global initiatives. No line reports.
A role with some travel away from home, and the chance to really influence best practice and work within a structure where innovation is encouraged and enabled.
Duties:
Enable standardisation and process improvement in our client's study delivery within Clinical R&D Europe by:
Developing, evaluating and enhancing clinical project management process documents, tools and associated materials according to industry-established best practices.
Mapping processes and writing controlled documents, forms and templates for Global Development Operations.
Keeping familiar with Client-specific processes/requirements
Establishing and maintaining strong working relationships with Client CQA, Training and R&D/Clinical Research units in Europe and the US
Ongoing review of processes via Gap-analysis and feedback from Clinical Research Units (CRU) and other departments in order to identify areas for process improvements, and to develop and implement action plans.
Ensure input into training needs
Review and provide input into Worldwide Standard Operating Procedures and other controlled documents.
Review all relevant audit/inspection reports and participate in clinical audit/inspection feedback and responses to identify areas for process improvement.
Chair European SOP/Clinical Process Committee (CPC), gaining input from appropriate departments where applicable and representation of Europe on the Global Clinical Process Committee.
Provide expert ad-hoc advice to clinical research teams to support their activities in ensuring efficiency, quality and integrity in the work conducted by the department as well as compliance with relevant SOPs and regulatory requirements.
Identification and delivery of ongoing quality control activities.
Contribute to the strategic development of process improvement and working practice within Clinical R&D Europe so that continuous clinical process improvement is ensured.
Represent/ co-run the back room for R&D Europe for Regulatory Inspections.
Represent the department in R&D meetings and task forces.
Essential Skills & Qualification
A degree, nursing qualification or equivalent experience, in a science or health related discipline with an additional 8 years clinical research experience in either a CRO and/or Pharmaceutical company
Must have a minimum of 2 years experience as a Senior Clinical Research Associate (CRA) and 2 years Project Management experience
Quality Assurance experience is an advantage
Good understanding of European and Global clinical study requirements and experience of working within global project teams
Excellent understanding of ICH-GCP guidelines, regulatory requirements and current practices
Enthusiasm and knowledge for best practice within clinical research, process improvement and compliance with standard operating procedures and clinical trial regulations
Ability to process map highly complex global process and distill into effective SOPs and Process documents; then train those documents across the organization
Direct experience in co-hosting MHRA Inspections preferred
Strong interpersonal and communication skills, and the credibility^to build and maintain strong relationships in Europe and US
Supplementary Requirements:
Software Competence: Superior proficiency in use of all Microsoft applications and the ability to learn new systems and function in an evolving technical^environment
Valid Driving License: Essential
Working Language(s): English
Requirement for Business Travel: Yes
Flexible Working Hours: No
Employer: Pharmaceutical Company
Employment Type: Permanent
Hours: Full time
Office Based access near e.g. M40/M4
Employer Benefits:
Company Pension, Company Car, Car Allowance, Life Insurance, Private Healthcare, Dental Care, Flexible Package Plan, Stock Options/Purchase Plan, Bonus, Free gym, Free Bus, Childcare Vouchers. Relocation Assistance.
MS Office, MS Project, Clinical Research, Clinical Operations, Clinical R&D, CRA, CTM, CTA, GCP, Study Manager, EUCTD, ICH GCP, Project Manager, Clinical Study, Clinical Programme, Feasibility , Essential Documents, GCP, SOPs, Compliance, Training,^Quality Control, QC, EDC
GCP, Qualified Person, QP, Clinical QA, Auditor, GCP Inspection, PVG Inspection
Assigned Consultant: Ann Maloney at CSL Recruitment on 01932 234 689
Please feel free to call for a detailed Job Description or additional i