Company: CK Clinical
Closing Date: 22 Dec 16
Salary (£): Competitive
Charlene Dutchman is recruiting for an Operations Manager to join an Academic Health Science Centre in Manchester, on a part time (0.5 FTE) , temporary basis...
Charlene Dutchman is recruiting for an Operations Manager to join an Academic Health Science Centre in Manchester, on a part time (0.5 FTE) , temporary basis for 6 months in the first instance.
As the Operational Lead you will be responsible for enabling and supporting staff, in ensuring that studies managed through the Unit meet the requirements of all legal and regulatory obligations and the Department of Health's Research Governance Framework. The role includes the management of robust and effective clinical trials management systems and support for the strategic and operational clinical trials committees.
As an Operations Manager, you will have the following responsibilities:
- Responsible for the cost effective use of resources and management of workload within the Trials Unit.
- Ensure that there are appropriate procedures to ensure patient safety in the conduct of clinical trials.
- Responsible for reporting research activities to key external bodies as appropriate
- Provide annual and ad hoc reports of the Trials Unit activities.
- Responsible for the management of information systems to record and report clinical trial/research requirements in line with GCP and relevant research legislation and guidelines.
- Ensure that clinical trials are conducted in compliance with the EU Clinical Trials Directive, ICH Good Clinical Practice (GCP), NHS Research Governance Framework and associated implementation plans, and the requirements of the Data Protection Act and Caldicott Guidelines.
- Responsible the development, implementation and ongoing management of a portfolio of SOPs relating to the management of clinical trials within the unit.
- Development and provision of a rolling programme of research related training to ensure that staff within the unit are trained in SOPs relating the clinical research and wider research related legislation and governance standards.
- To identify the governance training needs for the conduct of the research supported by the trials unit.
- Responsible for the efficient and effective day-to-day management of the Trials Unit, including the management, leadership and co-ordination of the Trials Unit staff.
- Negotiation of commercial and non-commercial other contracts relating to Trials Unit activities.
- Ensure that agreements are in place for the conduct of clinical trials and that appropriate agreements are in place with participating sites and other collaborators.
- Ensure that the Trials Unit operates within agreed budgets.
- Promote the facilities of the Trials Unit so that commercial and academic research is developed.
- Responsible for collation/production of bids/business cases for capital the directorate/services, and co-ordination of large capital purchases as required
- Responsible for the production of activity and performance reports for the Division Board and Performance Committee meetings. Manage the implementation of risk management policies and procedures in relation to the trials unit's research activities.
- Monitor the performance of the Trials unit against its agreed objectives.
- Responsible for the management of the Trials Unit governance performance monitoring and reporting mechanisms so that compliance is assured.
As an Operations Manager, you will have the following qualifications, skills and experience:
- Educated to degree level in scientific discipline and PhD or equivalent highly desirable.
- Proven experience in clinical trials management and record of Senior Manager.
- Experience in the management of quality assurance and / or regulatory compliance
- Demonstrable evidence of sound financial planning and HR management
- Ability to lead, inspire and motivate others
- Excellent verbal, written and presentation skills
- Ability to write and present complex reports and to critically analyse and communicate ideas in complex situations
- Strategic and independent thinker
- IT and information and project management skills
- Able to understand the principles of research proposals covering a wide range of scientific subject areas .
- Experience within a teaching hospital setting, writing research grant applications, and developing strategies, policies and business plans is desirable
CK Clinical 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 CL37664 in all correspondence.
9 High Street
|Tel:||+44 (0)1438 743047|
|Fax:||+44 (0) 1438723800|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.