We are actively seeking talented Clinical Team Leads “with excellent project overview skills.
The Clinical Team Lead (CTL) manages clinical monitoring and site management activities in one or more countries. The CTL also provides training and coaching for the CRA teams in the assigned countries with regard to protocol, Case Report Forms and study-specific procedures.
The CTL will be involved in one or more (international) studies Julius Clinical is running. The CTL can either work as singular CTL on a study, or, in larger studies, as part of an (international) team of CTLs. The current CTL team at Julius Clinical consists of 7 CTLs, with whom knowledge and experiences are shared on a regular basis.
Tasks and responsibilities
- Together with the project manager, is responsible for planning, organizing and executing international clinical trials from initial set up to study closure;
- Manages the clinical activities in the assigned countries in accordance with previously defined performance indicators in terms of both quality and quantity and implements actions as necessary;
- Monitors the clinical activities in accordance with protocol, SOPs, applicable laws and ICH-GCP guidelines;
- Ensures that information is conveyed effectively between the sponsor, Project Manager and the CRA team;
- Will be in contact with the sponsor with regard to different clinical aspects;
- Ensures adherence of the CRA team to study timelines;
- Reviews monitoring visit reports;
- Performs accompanied site visits, if applicable;
- Contributes to the development of study-specific documentation;
- Trains CRAs with regard to protocol, Case Report Form (CRF) and study-specific procedures;
- Participates in, and jointly organises meetings for investigators and CRAs;
- Ensures the correct query process is followed in collaboration with Data Management;
- Ensures the correct reporting and follow-up of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions;
- Supports the CRA team during inspections by healthcare authorities or audits;
- Ensures the reliable documentation and archiving of study documents, both at the study site and ‘in-house’.
- Higher level of education preferably in a (bio)medical field;
- A minimum of 3 years’ experience as CRA in the pharmaceutical and/or CRO industry;
- Experience in coaching and training of CRAs is a pre;
- Experience with therapeutic area cardiovascular and/or CNS is a pre;
- Up-to-date knowledge of legislation and regulations and ICH/GCP guidelines;
- Experience with multi-centre, international studies;
- Experience with regulatory / EC submissions/ start-up phase of clinical studies;
- Adequate command of written and spoken Dutch and English.
Our company culture can best be described as dynamic, open, co-operative, motivational, collegial, and inspirational. We set clear goals, work hard to attain them, and celebrate our successes.