TCTU Portfolio Trial Manager (BE-GENOMICS) - UOD2364

Tayside Clinical Trials Unit, Faculty of Health
Part time, 0.5 fte, 24 months fixed-term
Grade 7 (£37,694 to £46,049)

We are recruiting an experienced and motivated Portfolio Clinical Trial Manager to support the trials managed by Tayside Clinical Trials Unit (TCTU). This post is a 24 month fixed-term appointment until but may be extended subject to grant income. We have funding for a 0.5 full time equivalent post but job share and secondment will be considered. Please refer to job description for more information on the post roles and responsibilities.

As a TCTU Portfolio Trial Manager, you will join an existing team, working across new and established drug and complex intervention trials. You will take a lead role in all aspects of trial management, including providing support and advice on the approval process, trial management, recruitment strategies and data quality. You will liaise closely with the TCTU team, Chief Investigators, and site staff, ensuring TCTU trials are conducted to the highest scientific and regulatory standards. You must have excellent communication and organisational skills as well as the ability to prioritise your activities and work to tight deadlines, triaging and delegating activities when appropriate. As well as supporting the portfolio of TCTU trials, you will lead the BE-Genomics trial, "A Clinical Trial of Genome Sequencing to identify treatable rare disease in bronchiectasis " a multicentre trial, recruiting across UK managed by TCTU. UK and international travel may be required, subject to current restrictions.

Based in Ninewells Hospital, one of Europe's largest teaching hospitals, the Faculty of Health provides outstanding medical education and training supported by world class research facilities.

Your priorities will include:

* Obtain/assist with applications for initial regulatory approvals and subsequent amendments
* Maintenance of study documentation, centrally and at sites
* Monitoring and reporting on trial progress against agreed timelines and milestones
* Establish effective communication strategies with all stake holders
* Manage procedures for data collection and data verification to ensure data quality

Who we're looking for:

* First degree in biomedical, life sciences, healthcare or other relevant discipline
* Proven experience of working in clinical trial/project management setting
* Experience of data management processes, including use of electronic CRFs
* Good working knowledge of current scientific, regulatory and ethical frameworks defining trial management activity
* Excellent IT skills including MS Office and electronic data management systems

For further information about this position please contact Dr Fiona Hogarth, Co-Director, TCTU, [email protected]. To find out more about TCTU, please visit https://www.dundee.ac.uk/tctu. TCTU is an operational sub-unit of TASC.

At the University we benefit from having access to a range of personal and professional development courses and training opportunities. We enjoy 42 days annual leave per year and are supported by a range of Work Life Balance policies, staff support networks for BME, Disabled and LGBT staff, membership of Athena SWAN, the ECU Race Charter and Stonewall as well as a full range of disability services which all create an enjoyable and inclusive place to work. It is the diversity of our staff and students that make the University of Dundee an enjoyable place to work.