Clinical Project Manager
Rob Angrave is looking to recruit a Clinical Project Manager to join our client based in Cheshire.
You will responsible for planning and implementing the team objectives for clinical trials and delivering to time and budget.
I am looking for a driven CPM that will plan and manage the clinical trials in order to ensure the safe, effective and efficient delivery of all operational aspects of studies through all phases of study management in accordance with appropriate quality standards.As the CPM you will be accountable for the development, project management and delivery of site management plans and will work closely with clients and colleagues within the business in order to understand the requirements and deliver against these successfully.
- Develop the initial scope of work for clinical projects, working with the client and the Clinical team to clearly define the requirements, project costs/budget and resources
- Develop a quality management plan and associated risk log for all projects
- Lead the resourcing of study teams and the study site set up, contributing to the study feasibility, site selection, resource plan and driving the first subject in, ongoing recruitment, risk management and study delivery plan
- Lead the site management activities including the development and management of regulatory documentation, scheduling and management of all site visits in line with the agreed client contract requirements
- Proactively interface with the Clinical team and the client in order to manage the project and develop solutions to issues and challenges which arise
- Provide clinical operational expertise for the local study team and ensure compliance at all times with company governance guidelines
- Coordinate the daily operations of the Clinical team, including definition of the project timelines with the assigned study team, coordination of the remote review of clinical data, review and approval of trip reports and follow up, management of project meetings and ensuring the provision of required training for the CRAs
- Manage the delivery of study milestones and patient recruitment targets by the team proactively addressing deficiencies/deviations· Manage all project resources, including conducting regular reviews of budgets, ongoing monitoring of costs and potential overruns and the implementation of proposals for cost-effective solutions/mitigation strategies as required
- Manage and control allocated budget spend for the areas of responsibilities within this role
- Develop, implement and maintain company policies for which you are the named Subject Matter Expert
- Contribute to proposal generation and participation in bid defence meetings
Education and Experience
- Degree or equivalent qualification
- Advanced knowledge of good clinical practice and understanding of local Competent Authority regulations is required; international clinical trial experience and knowledge of other country requirements is preferred
- A minimum of 5 years' clinical study management experience in biopharmaceutical industry including a minimum of 3years in oncology and 2 years as a clinical study lead/project manager is required; global clinical trial experience is highly preferred
- Proven ability to influence and manage both clients and investigators.
- Ability to lead and influence in a fast paced and collaborative environment
- Excellent interpersonal, negotiation and conflict resolution skills
- Proven ability to lead projects and motivate at all levels
- Can operate on the big picture as well as with detail
- Excellent presentation skills, with solid oral and written communication capabilities
- Strong technical skills using PowerPoint, Excel and Word
For more information or to apply for this position, please contact Robert Angrave on 01246 457733 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47395 in all correspondence.