General Electric Clinical Compliance Associate in Various, United Kingdom
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There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can.
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As the Clinical Compliance Associate you will support ongoing clinical trials activities, both internal and outsourced to external CROs and Investigator Sponsored, by supporting compliance oversight of clinical activities, processing and review of study documentation to assure it is managed and in accordance with ICH-GCP, SOPs, Work Instructions and all other applicable regulatory requirements and guidance. Are you looking for an exciting opportunity to join a global company? Apply today!
• Support the identification of compliance issues across Imaging R&D systems and processes with a view to strengthening Quality to ensure a state of readiness for regulatory inspection.
• Support processing of Imaging R&D Corrective and preventative actions (CAPAs) (including those identified by audit / inspection) and facilitate resolution and closure within required timelines.
• Support maintenance of the GE eTMF and Document Management System, including User acceptance testing and perform training of users as required.
• Perform compliance reviews of clinical trial documentation according to GE vendor oversight processes to assure adequacy, completeness, timeliness and availability of documents.
• Provide input and updates to GEHC SOPs to assure that they are current and up to date according to regulatory and process requirements.
• Facilitate and support tracking of training for Imaging R&D and Medical Affairs personnel, ensuring that training is completed and documented appropriately.
• Support work with Regulatory Affairs (RA) to provide required updates for clinical trial information to regulatory agencies (e.g., clinicaltrials.gov).
• Collaborate with Medical Affairs, PV, RA, Supply chain as required to support clinical trials and to ensure compliance with relevant SOPs, including Investigator Sponsored trials (ISTs) and non-interventional post marketing studies
• Support Investigator Sponsored Trials (ISTs) by facilitating tracking, processing and review of relevant documentation in accordance with relevant SOPs
• Support process improvement and simplification initiatives by working in conjunction with internal and external partners.
• Working knowledge of Good Clinical Practice (GCP) within the Pharmaceutical Industry
• Good written and oral communication skills
• Ability to work independently and systematically
• Clinical trails experience
• Willingness to travel if required
Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website
• Auditing experience
• Regulatory experience
• Some Clinical Research experience or equivalent is preferred
Locations: United Kingdom, United States; Massachusetts; Amersham
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.