Mary Bolt is recruiting for a Clinical Research Pharmacy Services Senior Manager to join a world leading pharmaceutical company at their site based in Uxbridge on a contract basis for 12 months.
The Clinical Research Pharmacy Services team is a highly talented group of Pharmacists dedicated to oversight of Investigational Product in the company's studies. This team has an intimate understanding and insight into trial site practice, provides investigational product clinical services and relays how Investigational Product should be handled and managed within clinical sites. The team drives and contributes to continuous process improvement relating to Investigational Product.
Working within Global Development Operations, the Clinical Research Pharmacy Services Senior Manager will support Global Clinical Program Management (GCPM) to develop Investigational Product (IP) documentation and training and assist with the resolution of IP quality issues across sites.
The main purpose of the role will be to:
- Provide input and support into the design of IP sections of study protocols
- Provide input and feedback on drug packaging and labelling proposals for clinical studies
- Assist in the development and implementation of preventive actions and process improvement initiatives related to Investigational Product (IP) Management
- Support internal stakeholders & networks to promote greater cross functional understanding and insight into clinical IP needs, IP presentation and preparation challenges
- Identify and support site challenges related to the clinical preparation, labeling, packaging and administration of IP and bring these issues to the appropriate team(s) within the company for analysis and mitigation
- Investigate potential IP risks identified at clinical sites and assist CRA/study teams with resolution and action plans
- Identify IP management training needs and develop support tools as required by the company and site personnel
- Support development and regular review of Investigational Product Instruction Manual (IPIM) template, IPIMs and associated documents
- Act as the primary point of contact on behalf of the company for study related IP Management questions
- Understand the capabilities of the clinical sites to inform internal testing of representative materials and delivery approaches
- Provision of subject matter expert input and support into organizational process improvement initiatives
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Registered Pharmacist and pharmacy degree
- Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials as well as familiarity with advanced concepts of clinical research
- Extensive knowledge of ICH/GCP regulations and guidelines and strong knowledge of clinical trial operations
- Detailed understanding of customer service and a demonstrated ability to anticipate and resolve problems
- Staff management and development needs and experience in a project leadership role
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 CL39562 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 14th July 2017
- Expires: 11th August 2017
- Reference: CL39562