Company: DOCS Global
Location: Marlow,United Kingdom
Reference: Ref AS-020373
Closing Date: 25 Feb 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 reply to this role and a DOCS Recruitment specialist will contact you to discuss the position in detail. Please send your CV* today to find out more details to Elisabeth.Knighton@docsglobal.com or ring +33 964 25 67 65.
Roles & Responsibilities of the position
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 Global Project Manager. The Global Project Manager will be responsible for the planning and management of clinical studies conducted by globally through the leadership of the cross-functional teams .
Key Responsibilities include:
• Leading and continually reviewing risk mitigation activities to ensure study delivery to plan
• Contributing to study-level risk assessments
• Identifying and resolving issues at a global level
• Reporting study progress at appropriate forums and to management
• Collaborating with Regional CTM to ensure country level study delivery aligned with global delivery plans
• Overseeing global insourcing/outsourcing partner deliverables to the required standards
• Managing study-level budget and timelines
• Partnering with different teams/departments - to ensure vendor set-up, conduct and quality oversight of deliverables
• Leading global study-level documentation and required tool and systems set-up
• Leading development and implementation of global 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 and relevant international regulations and guidelines
• Strong clinical development process and procedures expertise
• Project management 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, etc.
• Minimum prefered qualificaiton /BSc or RN or above
• Broad experience working in life sciences or medically related field
• General pharmaceutical clinical research experience obtained working on commercial clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of external clinical research vendors (CROs, central labs, imaging vendors, etc.) highly preferred
• Full-time availability
• Full and valid UK working eligibility
• Full and valid driving licence
• Start date: negotiable.
Project Management / Risk Assessment / Critical Thinking and Planning / Matrix Team / Organizational Leadership / Metrics Analysis / Strong Written and Oral Communication / Delivery Focus / Decision Making / Relationship Management / Conflict Resolution / Problem Solving / Adaptability and Flexibility
Permanent contract of employment;
Office-based in Bucks (UK) or in Eastleigh (Hampshire). For office-based GCTMs, some home-working flexibility could be allowed;
Market leading salary ranging depending on level of skills and experience, plus company benefits (25 days annual leave, car allowance, bonus, pension, life assurance, healthcare cover),
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