The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.
The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.
We are currently looking for an enthusiastic and talented contractor Clinical Team Lead (CTL) based in the UK.
The anticipated resource requirement is up to 0.4 FTE.
As Clinical Team Lead you will be responsible for the development and implementation of project-specific plans for recruitment, monitoring and management of clinical sites in accordance with contractual agreements, work instructions, guidelines, procedures, applicable international, federal and state regulations, and ICH-GCP. As the primary point of contact for the CRA team, you'll provide daily supervision of the Clinical Research Associates (CRAs) assigned to your studies and updates on the progress of study activities to the Project Lead. This role will also require you to be responsible for the CRA role and responsibilities for sites in the UK.
Key Responsibilities:
* Primary point of contact for the CRA team on assigned studies
* Proactively manage and train CRAs, both employees and contractors, and administrative staff.
* Provide clinical and technical direction and guidance to the project team, developing and implementing project-specific plans for recruitment and monitoring, reviewing CRA reports and identifying trends and any areas of concern, coordinating all monitoring activity and communicating the progress of activities to the Project Lead.
* Oversee management of communications and relationships with sites
* May act as Project Lead on projects as needed.
Qualifications and Attributes:
* Proven track record in a customer-facing Lead CRA or Clinical Trial Manager role with extensive experience managing CRAs.
* Contract Research Organisation (CRO) background preferred
* Strong problem solving, organizational and time management skills. Ability to multi-task and attend to detail.
* Therapeutic area experience in oncology and/or radiopharmaceuticals
* Bachelor's degree or equivalent in training and experience
* Ability to handle challenging clients
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