Clinical Trial Team Leader

Employer Information

Randox

E: recruitment@randox.com

T: +44 (0) 28 9442 2413

W: https://www.randox.com/

Clinical Trial – Team Leader (22N/CTTL)

Randox currently have an opening for a Clinical Trial Team Leader. This opportunity can be based in our Science Park in Antrim, Northern Ireland or our sites in London or Liverpool. If based in London or Liverpool travel to our Science Park in Northern Ireland will be required.

The Role:
•    The smooth and efficient running of RCLS Clinical Trial Team ensuring that all laboratory- based testing for clinical diagnostics is conducted accurately in conjunction with Randox Clinical Laboratory Services Standard Operating Procedures (SOPs) and in-line with ISO/IEC 17025 (2017), ISOIEC 15189 (2012) and Good Clinical Practice (GCP) guidelines. 
•    Primary point of contact for Clinical Operations aspects of designated projects and;
•    Responsible for planning, scheduling, and implementing the Clinical Operations aspects of projects
•    Contribute to the development and maintenance of cross functional project management plans
•    Oversee monitoring activities and conduct co-monitoring visits to ensure data quality.
•    Provide study specific direction to study team members and ensure that they are regularly updated on the study progress, challenges and risks throughout the duration of the study
•    Ensure proper study documentation is maintained and archived in the TMF
•    Responsible for risk mitigation strategies, associated action plan and issue resolution
•    Ensure the correct reporting and follow-up of Adverse Events, Serious Adverse Events, and Suspected/ Unexpected Serious adverse reactions
•    Monitor the clinical activities in accordance with protocol, SOP’s, applicable laws and ICH-GCP guidelines
•    Manage the Clinical Operations project team, including ensuring all necessary project training is provided to assigned staff
•    Provide direction and support to the Clinical Operations study team
•    Track clinical Operations project deliverables using appropriate tools
•    Monitor employee productivity and provide constructive feedback as well as assisting in the identification and management of Non-Conforming work identified within the laboratory
•    Ensure that remedial actions are taken when test systems deviate from the laboratory established performance specifications or which result in down-time of any instrumentation and communicate this with the lab manager.

The Person 
•    Excellent practical skills
•    The efficient and effective use of resources
•    The ability to interpret and analyse data
•    Anticipates needs and issues and takes action accordingly
•    High attention to detail and a thorough approach
•    Be able to effectively plan, develop and implement policies
•    Possess a positive attitude

Essential
•    Experience in delivering global clinical trial programmes
•    University/bachelor’s degree in medicine, science or equivalent degree/experience
•    Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials
•    Some knowledge of project management processes and tools
•    Excellent verbal and written communication and organisational skills
•    Excellent leadership and team working qualities
•    Strong work ethic and self-starter, able to effectively manage multiple priorities and adapt to change within a fast-paced environment
•    Knowledge of variety of software packages such as Microsoft Word, Outlook, PowerPoint & Excel

Desirable
•    Satisfactory progression from monitoring experience with previous experience in leadership and/or management activities

Apply for job