Clinical Trial Manager / EU studies / Bucks / England

3 x Clinical Trial Managers, pan-European studies The ideal candidates will have current experience as a Clinical Trial Manager or Clinical Study Manager. We are looking for experienced Clinical Trial Managers to: · Lead and manage the conduct of clinical trials from study start-u p to close-out across several European countries in accordance with ICH-GCP and applicable local regulations · Collaborate with Clinical Trial Managers (and the Global Clinical Trial Manager for global execution of study(ies) · Maintain the quality and scientific integrity of clinical trials across multiple countries · Collaborate with cross-functional internal and external stakeholders to ensure timely and on budget execution of clinical trial deliverables within multiple countries The Clinical Trial Manager will look after European clinical studies and will be responsible for leading the regional matrix team, including CRAs, CTAs and additional staff, to ensure delivery of country and site level study activities in alignment with the global study project plan. Experience of leading/managing pan-European studies is essential. Key Responsibilities include: · Identifying and resolving issues at a regional level · Collaborating with Global Clinical Trial Manager(s) to ensure country level study delivery is aligned with the global study project plan · Contributing to study-level risk assessments · Leading and continually review regional risk mitigation activities to ensure study delivery to plan · Overseeing regional insourcing/outsourcing partner deliverables to the required standards · Ensuring regional, country and site vendor set-up, conduct and quality e.g. laboratories and equipment provisioning · Leading regional documentation and required tool and systems set-up · Contributing to regional aspects of Drug Supply Plan · Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines · Supporting audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate · Executing regulatory agency inspection readiness activities (e.g. TMF review, story board generation) within region · Supporting and contributing to Clinical Study Team(s) · Ensuring relevant systems are updated to enable accurate reporting of study progress and milestone deliverables · Ensuring key stakeholders are kept informed of study progress e.g. Global Clinical Trial Managers, etc. · Contributing to development of study-specific materials e.g. monitoring plan, study specific training documents · Participation in cross-functional task forces / process improvement groups Critical Success Factors for the Role include: · Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and applicable international regulations and guidelines · Clinical Development process and procedures · Project planning experience including oversight of study deliverables, budgets, and timelines · Ability to use scientific and clinical knowledge to conceptualize study designs · Experience anticipating and resolving problems · Experience writing and presenting clearly on scientific and clinical issues · Experience collaborating and leading cross-functional teams (team/matrix environment) · Knowledge of project risk management assessment and mitigation approaches What is required • BA/BS/BSc in the sciences or RN • Ideally, a minimum of 7 years work experience in life sciences or medically related field, with ideally at least 4 years clinical research experience obtained working on clinical trials either within a biotech, pharmaceutical or CRO company • Proven track-record of European clinical studies (commercial/industry-sponsored studies) • Experience in working with external clinical research vendors (CROs, central labs, imaging vendors, etc.) • Full-time availability • Full and valid UK working eligibility • Full and valid driving licence • Ideally able to start asap/negotiable Key Competencies: Project Management / Risk assessment / Critical Thinking and Planning / Matrix Team organization/leadership / Metrics analysis / Written and oral communication / Delivery focus/Decision Making/Problem solving / Relationship management / Conflict resolution / Adaptability and Flexibility / Working in virtual teams What is offered Permanent contract of employment with DOCS seconded to the client; Full-time; Office-based in Marlow (Buckinghamshire/England) Office-based comes with the flexibility of 3 days in the office and 2 days home-working; Competitive salary depending on level of skills and experience; Company benefits: 25 days annual leave plus UK bank holidays, car allowance, p ension and healthcare. Why Join DOCS? If you are a Manager with commercial clinical pan-European studies experience, please contact me now with your CV Applicants who have not had a response within two weeks should assume their application has been unsuccessful. This job was originally posted as www.totaljobs.com/job/89855825