CLINICAL TEAM LEAD
We are actively seeking talented Clinical Team Leads.
JOB OVERVIEW
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
You will:
- 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;
- Ensures adherence of the CRA team to study timelines;
- Reviews monitoring visit reports;
- Performs accompanied site visits;
- 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’.
DESIRED SKILLS AND EXPERTISE
- 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;
- Adequate command of written and spoken Dutch and English.
WE OFFER
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.
Additional information
This position/ vacancy is for at least 32 hours.
HOW TO APPLY
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