Senior Clinical Trial Manager

I am thrilled to be partnering with a company that is working on a profound project that will change the medical space.

They are looking for a Senior Clinical Trial Manager to work remotely from the UK ( London preferably) with travel every 4-6 weeks to Ireland and the USA.

This is a permanent position with attractive remuneration.

You will be responsible for overseeing all clinical studies related to the product developed by the Company. You will also be responsible for ensuring the planning, implementation and management of Clinical Trials and other related activities by designing and executing studies to support regulatory submissions and post-market surveillance.

Responsibilities:

• Develop and execute clinical research strategies, plans, and budgets for the product in compliance with regulatory requirements.
• Oversee the design, implementation, and management of Clinical Trials, including protocol development, site selection, patient recruitment, and data collection and analysis.
• Collaborate with cross-functional peers including regulatory affairs and product development to ensure alignment of clinical research activities with overall business goals and objectives.
• Ensure that all clinical research activities are conducted in compliance with applicable regulatory requirements and ethical standards.
• Manage relationships with clinical research organizations, investigators, and study sites to ensure high-quality, timely, and cost-effective execution of Clinical Trials.
• Prepare and submit clinical study reports and other regulatory documents to regulatory authorities and other stakeholders.
• Manage the clinical research budget and resource allocation to ensure efficient and effective use of resources.
• Present clinical study data and results to internal and external stakeholders, including peers, regulatory agencies and scientific conferences.
• Respond to changing priorities and timelines in an efficient and effective manner, while maintaining structure under pressure.

Skills & Qualifications:

• Advanced degree in life sciences, health sciences, or a related field.
• Minimum of 5+ years of experience in clinical research.
• Strong knowledge of FDA regulations, ISO standards, and GCP guidelines related to clinical research.
• Excellent communication skills
• Strong analytical and problem-solving skills, with the ability to identify and mitigate risks associated with clinical studies.
• Experience in presenting clinical study data and results to internal and external stakeholders, including regulatory agencies and scientific conferences.
• Leadership of projects