Company: Docs Global (Continental Europe)
Reference: Ref AS-020263
Closing Date: 26 Feb 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
DOCS is the Functional Resourcing Division of ICON Plc. This means that when someone joins the DOCS Team rather than working in a CRO environment you will be directly insourced with one of our many pharmaceutical / medical device partners working on their SOPs, IT Systems, Projects and sometimes in their offices. We now have a brand new role exclusive to DOCS for an experienced Clinical Project Manager to be fully insourced and onsite at a growing biotech in Dublin.
Roles & Responsibilities of the position
There have been some delays in getting the studies started as they were meant to be up and running now so the Clinical Project Manager will have the opportunity to:
• Manage the vendor appraisal and selection – this will include CROs and Labs for Phase II/III Studies
• Manage the budgets and proposals
• Responsibility for oversight on the Orphan Drug Program – hugely exciting
• It would be advantageous to understand the start-up process and the intricacies and possible risks and solutions with this on global basis
• You would take oversight responsibilities of the selected vendors
• You will essentially be responsible for all operations aspect of the clinical trial
• This is full trial execution from protocol generation, input to clinical trial report, writing and publications and essentially full accountability for the study deliverables
As this is a small biotech away from the clinical responsibilities you could get exposure to other functions such as regulatory affairs, QA, Sales etc… This is rare and a unique selling point of this role
Requirements / Experience:
• Significant Clinical Operations experience with managerial experience in planning, executing, and reporting clinical studies in a pharmaceutical company or contract research organisation.
• Proven ability to work independently.
• Good project management and communication skills
• Ability to resolve issues with minimal supervision and work well under tight timelines to deliver results
• Thorough knowledge of Good Clinical Practice, clinical trial design, data management operations, general understanding of regulatory environment, and global clinical drug development process.
• Effective site management and organisational skills, with ability to establish and maintain effective working relationships with third party vendors, senior management and co-workers
To find out more about this role please use the following contact details:
+44 207 832 2306 / Philip.Jones@docsglobal.com
Please note that this role is only accepting applications from those with current working rights in Ireland
2 Globeside, Globeside Business Park
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