OVERALL ROLE OBJECTIVE

The Clinical Project Manager will be responsible for the overall management of a variety of company and investigator sponsored clinical studies.

The trials will be conducted in the UK and the European Union.

The Clinical Project Manager will join TC BioPharm Ltd (TCB), an emerging cancer immunotherapy company developing cell-based treatments for cancer and severe viral infections. Based at their manufacturing facility in the central belt of Scotland, the successful candidate will report directly to the Director of Clinical.  TCB is a fast growing, immunotherapy company developing cell-based treatments for cancer patients; moreover, our unique culture, values and working environment attracts, retains, and inspires people to give their best.

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Coordinate all aspects of Phase I/II clinical trials.
• Manage the production of all documents essential to the performance of clinical trials including protocol development and project/development plans.
• Prepare detailed timelines and establish milestones for assigned project.
• Prepare, monitor and manage study budgets for assigned clinical trials.
• Oversee the activities of other members of the project team.
• Liaise with other functions, some of which may be at a CRO, including Pharmacovigilance, Regulatory Affairs and Medical Affairs to ensure all required documentation/activities are completed within the required timeframes.
• Organise and participate in Investigator and Monitors meetings.
• Oversee the supply of investigational medicinal products (IMPs) to trial sites.
• Ensure all of the necessary approvals and documentation are in place for each study site prior to authorising the start of recruitment, or the dispatch of IMP to the site.
• Circulate regular progress reports for assigned clinical trials to relevant individuals.
• Develop and maintain therapeutic expertise in relevant disease areas.
• Create and maintain strong relationships with the investigators and their teams to support the clinical development, regulatory and commercial strategies.
• Ensure, on an ongoing basis through careful monitoring, that studies are conducted, recorded and reported within the agreed timelines and budget, and in accordance with applicable SOPs, ICH-GCP and other applicable regulations and guidelines.
• Be prepared to travel internationally for the role.
• Be prepared to take up line management
• Any other ad-hoc tasks as required.
• Primary contacts:  Director of Clinical, Scientific and Medical Director, Clinical Research Associate Manager, Clinical Research Associate, Clinical Trials Administrator, Pharmacovigilance Officer, Medical Monitor, Clinical site staff, Contracted CROs.

QUALIFICATIONS

A degree in a life science discipline or medical degree

SKILLS & EXPERIENCE

• Minimum of 3 years’ experience of working as a Clinical Project Manager
• Experience in oncology/haemato-oncology early phase studies
• Experience with ATMP/cell therapy an advantage
• Thorough knowledge of ICH GCP and other industry-recognised standards and guidelines.
• Experience of interacting with regulatory authorities and ECs an advantage
• Experience of working with CROs and multi-national teams
• Ability to manage activities of other individuals (e.g. members of the project team, investigators, laboratories, contractors)
• Experience in line management an advantage.
• Proactive approach with high levels of initiative, energy and commitment
• Flexible and able to adapt quickly to changing plans and priorities
• Excellent inter-personal, presentation and written communication skills
• Good organisational and prioritisation skills ensuring time and workload are managed effectively
• Ability to think innovatively
• Capable and willing to work with a high degree of autonomy
• Ability to work closely as part of a multi-functional team.
• Excellent written/oral communication and interpersonal skills
• Excellent Microsoft Office skills
• Thorough approach and high attention to detail
• Strong time management and organisational skills

If you are looking to work within a challenging, dynamic, and rewarding environment, then TCB represents an excellent career move. This is an opportunity to be part of a growing, ambitious business where people development is critical to future success.  As we continue to expand, there will be career opportunities on a truly global scale.

TCB is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. 

Office based role 37.5 hours per week – normal office hours apply.