Senior Clinical Study Manager

Permanent Position

Remote (will involve UK and international travel)

Salary up to £80,000 + bonus + competitive benefits

Are you an experienced study manager within clinical research?

Are you looking for a senior, rewarding role within clinical study management in the pharmaceutical industry?

My client are a leader in delivering high quality, processed biological materials across the UK and globe, with a large portfolio of therapeutics at market and in development. Due to continued growth, they are looking to bring onboard a Senior Clinical Study Manager who will take ownership of studies across the business, including a large upcoming international trial.

The Senior Clinical Study Manager will manage the delivery of clinical studies, from study set up through to final report review and submission, interacting with key stakeholders internally and at partner Clinical Research Organisations (CRO’s).

Due to the nature of the role and global presence of the organisation, there will be a requirement for travel within the UK and internationally (Europe and US).

Key responsibilities of theSenior Clinical Study Managerinclude:

• Oversee and ensure the delivery of phase I to IV clinical trials from set up, through to recruitment, study initiation, close-out and final report submission.
• Ensure successful relationships with external stakeholders and partners are maintained, including Clinical Research Organisations (CRO’s), vendors and at study sites.
• Monitor study timelines, ensuring key milestones are achieved as planned, and addressing any potential risks.
• Manage large study budgets, making decisions on expenditure independently.
• Ensure studies are conducted in accordance with applicable regulatory requirements, standard operating procedures (SOP’s), Good Clinical Practice (GCP).
• Conduct external audits and investigations to maintain regulatory compliance, ensuring the resolution and closure of any findings.
• Provide frequent updates on study status, including at project meetings and within the wider clinical research team.
• Contribute to organisational process improvement initiatives.

To be considered as aSenior Clinical Study Manager, you will need the following skills or experience:

• Significant experience within clinical study management within the Pharmaceutical, Bio-Pharmaceutical or Biotechnology industry, working directly within the sponsor organisation.
• Experience handling large clinical budgets (in the millions), able to make independent decisions on expenditure.
• A strong working knowledge of Good Clinical Practice (GCP) and associated regulatory standards.
• Experience working across Phase I to IV trials.
• Able to plan and manage clinical studies, providing regular reports and updates to ensure projects run to time and budget.
• Excellent communication skills and a personable nature, to support relationship building with stakeholders and cross functional teams.
• Strong written skillset in order to prepare technical scientific reports, documents and presentations.
• BSc/MSc/PhD in a scientific subject (Biomedical Science, Biochemistry, Biology, Pharmaceutical Science, Chemistry etc.) or equivalent working experience.
• Comfortable travelling as needed within the UK, Europe and US.

Please apply online or contact Katie-May Kress at CY Partners for more information.

Keywords: Senior Clinical Study Manager, Clinical Study Manager, Clinical Study Lead, Clinical Trials Lead, Study Lead, Study Manager, Clinical Research, Clinical Studies, Clinical Trial, Good Clinical Practice, ICH-GCP, GCP, GxP, Sponsor, Pharmaceutical, Bio-Pharmaceutical, Biotechnology, CRO, Clinical Research Organisation, Remote, UK, US, Europe”

The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. CY Partners Recruitment Ltd, trading as CY Partners is an Employment Business/Agency.