Hobson Prior are looking for a Clinical Trial Manager to join a fantastic biotech organisation on a 12-month contract basis located in Uxbridge. Our client is focused on advanced medicines for serious diseases.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this position, you are responsible for providing regional management of global PIb-III studies that are managed by Clinical Program Manager.
• You will be responsible for outlining and coordinating reviews of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
• Maintain study timelines.
• Contribute to the development of study budget.
• Contribute to the development of RFPs and participates in selection of CROs/vendors.
• Manage CROs/vendors.
• Coordinate the review of data listings and preparation of interim/final clinical study reports.
• Contribute to the development of abstracts, presentations, and manuscripts.
• Ensure the effectiveness of site budget/contract process.
• Train CROs/vendors/investigators/study coordinators on the study requirements.
• Operate alongside the Clinical Program Managers to manage regional component of Virology clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes.
• Interact with the cross-functional teams internally and externally to confirm trial progress.
• Any other assigned duties.

Key Skills:

• Ability to resolve problems using national and international regulations, guidelines, and investigator interaction.
• For this position, you will have exceptional teamwork, decision-making and organisational skills are key to success.
• You will have strong communication skills.
• You are inquisitive with a strong learning agility (the ability to rapidly study, analyse and understand new situations and problems).
• Operationally excellent and resilient in the context of a rapidly changing environment.
• Organised with systematic approach to prioritisation.
• Display the Core Values of the company - Integrity, teamwork, excellence, accountability, and inclusion.

Requirements:

• It is essential to have substantial applicable experience and a BSc or nursing qualification in a relevant scientific discipline.
• Former study management/coordination experience at a senior CTMA level.
• Monitoring experience is highly desirable as co-monitoring will be required.
• Able to generally understand, interpret, and explain protocol requirements to others.
• You are required to have the ability to prioritise multiple tasks.
• Participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
• Must have a general, functional expertise to support SOP development and implementation.
• Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Previous experience in Virology areas would be advantageous but not essential.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.