Ref #: 27124

Employment type: Permanent - Full-Time

Location: Buckinghamshire

Posted: 23-Feb-2021

Description

Clinical Trial Manager, pan-European studies Office-based (Bucks or Hampshire) / UK

We are looking for Clinical Trial Managers to:

• Lead and manage the conduct of clinical trials from study start-up to close-out across multiple 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

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 at either Marlow (Bucks) or Eastleigh (Hampshire);
• 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, pension and healthcare.

Why Join DOCS?
If you have pan-European studies experience with the pharma/CRO industry, please send your CV today to find out more details to Elisabeth.Knighton@docsglobal.com or ring +33 964 25 67 65.

*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.
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