Lead Clinical Team
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Clinical Research, Medical Devices and Pharmaceutical organization, based in Noord-Holland Netherlands.
The client is specialised in global clinical trials.
ROLE DESCRIPTION
- Managing clinical monitoring and site management activities.
- You will provide training in protocols, procedures for the study specific and coach the monitoring teams.
- As the lead of the Clinical team you will report to the project manager.
RESPONSIBILITIES
- Monitoring the progress of the clinical activities according protocols, ICH/GCP guidelines and SOPs.
- Reviewing the reports from monitoring visits of clinical trials
- Makes sure that local teams study the timelines
- Contributes to the development of documentation specific to study's;
- You will train the CRAs regarding protocols, Case Report Forms and procedures specific to a study.
- You will organise and participate in meetings for investigators and CRA's.
- Make sure that the right query process is followed in collaboration with Data Management.
- Ensures the correct reporting and follow-up of all Adverse Events.
- During inspections or audits by Health Care organisations you will supports the study teams .
- You will ensure the documentation and archiving of study documents, and will make sure that the information will be shared between sponsor, project manager and the study teams.
REQUIREMENTS
- Bsc. or Msc. or Phd in biomedical field
- +3 years’ of experience as lead CRA in the pharmaceutical or CRO industry;
- Experience with the therapeutic area Oncology or Alzheimer
- Experienced with the coaching and training of CRA's
- ICH/GCP guidelines;
- Experience international trials
- Fluent in Dutch and English.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Michael Kooiman.
