This position is a member of the Product Development Team and is responsible for participating in design, performance and interpretation of clinical studies in support of Product Development activities.
Specific deliverables for the role are:
1. Alongside line manager and Clinical Affairs team, ensure clinical study protocols and associated forms are prepared and uploaded to ETQ.
2. Ensuring clinical study sites are adequately equipped to carry out studies (including movement and calibration of equipment and organisation of study material shipments).
3. Ensuring that studies are carried out in accordance with the Company’s Quality Management System and to the required Regulatory standards, in collaboration with the Clinical Affairs team.
4. Ensure all clinical study forms are correctly completed and the data has been entered into the correct database/filed appropriately.
5. Training study site staff in appropriate laboratory procedures.
6. Liaising with Clinical Affairs team to ensure studies run efficiently (answering technical queries relating to protocol/equipment etc.).
7. Travelling to internal and external sites at short notice to ensure project milestones are met.
8. Data verification, analysis and reporting
9. Presenting data at internal and external meetings, as required.
10. Taking responsibility for maintenance of databases and clinical information used by Oxford Immunotec Product Development Team related to clinical studies
11. May be required to carry out phlebotomy and to arrange and attend external and internal blood donations
12. Participate in data collection and entry for all of the Product Development studies (pre-clinical) and where required, the Clinical Affairs team
13. Ensuring that work is completed to agreed timelines.
14. Ensuring that any likely delays or issues with a given project are communicated to their line manager in a timely manner.
15. Working to Oxford Immunotec’s Company Values at all times.
Desirable Technical skills and abilities
• An understanding of the diagnostic and pharmaceutical industries
• Familiarity with Quality System concepts and requirements including GMP and ISO systems.
Essential Technical skills and abilities
• At least a BSc Degree or Equivalent in Life Sciences or Clinical Management
• At least 12 months experience in clinical trial design, set-up and execution
• Experience in clinical trial data management essential
• Knowledge of Windows and Office based applications; Word, Excel, PowerPoint.
• Ability to organise and prioritise workloads and work under pressure.
Emotional skills and abilities
• Capable of handling multiple tasks at the same time.
• Capable of working effectively in a team environment.
• Able to communicate effectively at all levels.
• Ability to adapt to changing project priorities
5 most important job specific skills
1. Breaks problems/project plans down into their component parts analysing links and potential implications
2. Shows pro activity in identifying and then overcoming problems.
3. Knows how their role fits in with the whole process
4. Takes responsibility for delivering the required results to the required standards
5. Acknowledges the importance of high standards and works to get things right first time every time
6. Keeps others informed about progress without needing to be prompted
7. Computer literate