EU Study Manager (Bucks or Hampshire)

DOCS Global
12 Oct 2018
14 Oct 2018
Contract Type
Full Time
Roles & Responsibilities of the positionThe project will provide exposure across a variety of therapeutic areas with an organization that is on the forefront of adopting new processes and technologies, creating a unique opportunity for career growth and development.

Critical to the project is the role of Regional Clinical Trial Manager. The RCTM (Regional Clinical Trial Manager) 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.

Key Responsibilities include:
• Identifying and resolving issues at a regional level
• Collaborating with Global PM 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
• Partnering with multi-disciplinary teams to ensure regional, country and site vendor set-up, conduct and quality
• 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

Critical Success Factors for the Role include:
• Working knowledge of ICH/GCP (International Conference on Harmonization / Good Clinical Practice, and applicable international regulations and guidelines
• Strong knowledge of clinical development process and procedures
• Project planning experience including oversightJob Requirements• BA/BS/BSc or RN
• Proven track-record of European clinical studies (commercial/industry-sponsored studies)
• Ideally over 6/7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of 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.Remuneration & other detailsWhat is offered
Permanent contract of employment
Office-based with the flexibility of 2 days home-working
Market leading salary ranging depending on level of skills and experience, plus company benefits

Send your CV now to find out more to 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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