Company: DOCS Global
Location: Marlow,United Kingdom
Reference: Ref AS-017999
Closing Date: 22 Jan 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Why Join DOCS? If you are an experienced clinical professional looking for an opportunity with a rapidly growing and fast paced global leader on an interesting and complex project this would be a compelling role for you. To express your interest 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.
Roles & Responsibilities of the position
DOCS has partnered with one of the world’s leading biopharma companies on a global study management initiative that has created exciting opportunities for professionals with clinical study management experience.
We are looking for talented and motivated candidates to join the team and take part in this long term, dynamic project. The 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 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 oversight
• BA/BS/BSc or RN
• Proven track-record of European clinical studies (commercial/industry-sponsored studies)
• Clinical study management gained in a biotech, pharmaceutical or CRO company
• At least 2 years clinical research industry experience
• Experience in oversight of outside clinical research vendors including 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.
What is offered
Permanent contract of employment
Office-based and/or home-based (home-working flexibility could be offered to the right candidates)
Market leading salary ranging depending on level of skills and experience, plus company benefits (25 days annual leave, car allowance, pension, life assurance, and healthcare cover)
Send your CV now to find out more 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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