Job Title: Clinical Project Manager - Field Based - England Wide
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Vacancy details
Vacancy description:
Job Code:
J773016
Job Title:
Clinical Project Manager - Field Based - England Wide
Job Category:
CRM (Clinical Research Management)
Contract:
Any
Discipline:
Clinical Project Manager
Country:
United Kingdom
Location:
Any Location
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
30 Sep 2010
Clinical Project Manager - Field Based - England Wide
A fantastic opportunity for an experienced PM with at least two years experience to join this Top Pharmaceutical company. This company, one of our top clients have excellent staff retention rates due to the level at which they treat all their employees, each person is seen as an individual and your personal development will always be a top priority. They take very seriously your ambition and aims in terms of what you wish to achieve from both the role and company. The role is a 12 month contract through clinical professionals , free lancing may also be an option however the first is a preference. Salary negotiable.
Purpose
• To manage clinical trials within the UK and across the Northern Europe CRD countries in accordance with the Company’s policies and procedures, SOP’s, Local Work Instructions (LWI’s)and ICH GCP requirements
• To oversee all clinical trials within a given drug development project
Outputs
• Milestones for all studies
• Clinical trials compliant with protocol, SOP’s, Local Work Instructions (LWI’s) and ICH GCP
• Project progress reports
• IMPACT maintenance
• UK site selection in line with business objectives
• Define project success criteria
• Coaching new staff members
Responsibilities
• Providing project and study management support for specified trials conducted within the UK, including reviewing protocols, assessing feasibility, planning resources and budget, risk analysis and developing a strategy for study implementation
• Co-ordinating clinical trial activities in the UK and across participating countries within Northern Europe, in accordance with SOP’s, Local Work Instructions (LWI’s) and ICH GCP
• Providing project sponsorship and supervision for clinical trials conducted within the UK and Northern Europe CRD countries, including strategic input and review of CDPs, liaison with Sales, Marketing and Medical Information, representing clinical trial activities outside UK, developing local strategies for project implementation and review and critique of clinical trial data
• Managing the relationships and service levels with CROs and other contracted organisations
• Co-ordinating and contributing to trial meetings and producing progress reports
• Contributing to ongoing process improvement
• Promoting standardisation and consistency between all trial participants
• Building and maintaining close relations with Data Management, Northern Europe CRD and HQ to ensure optimal integration of activity and trial delivery
• Maintaining current knowledge of therapeutic areas, SOP’s, Local Work Instructions (LWI’s) and ICH GCP guidelines
Requirements:
Previous Project Management experience
Proven success in managing clinical trials (desirable) including multi-centre studies.
Experience in more than one phase of development & international trial co-ordination desirable
Project and resource management skills
Understanding of clinical trial regulations across Europe
Excellent knowledge of clinical trial methodology
Up to date knowledge of the clinical trials environment - ICH GCP, regulatory issues, SOP’s
Knowledge of drug development process
Computer literacy and IT skills including SAP and IMPACT
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