Covance Clinical Team Lead in Herzliya Pituah, Illinois
We are currently looking for talented CPL to join our team in Israel would be working within our Flexible Solutions department (EMEA FSPx Team) dedicated to one sponsor/client.
Would you like to work for one of the best known big pharma companies? Our sponsor is a global mid sized pharma company with high working standards. Are you passionate about growing in Clinical Field? We are proud to have an excellent team of the best professionals on the market and are looking for people who are ready to show true performance and interest in Clinical Trials. Do you like responsibilities and challenges? As a Clinical Research Associate you will lead all aspects of study site monitoring according to Covance SOP, ICH guidelines and GCP. You will take part in pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
You will become a part of our team who is always ready to help. You will have a possibility to devote all your professional skills and knowledge into monitoring investigational sites as we organize our work environment and responsibilities with high standards.
Our sponsor invests heavily in training and crafts modern system of Clinical Trials so if you are passionate about working with an outstanding team and expand your horizons feel free to reach us
The CPL is a member of the Project Team and has overall responsibility and accountability for the execution of the clinical operations strategy of the project on a regional level.
The CPL is responsible for coordinating and managing the clinical operations and site services maintenance team, providing leadership and expertise to ensure successful execution of the site selection, clinical operations and IRB/IEC/regulatory maintenance project deliverables (quality, timeline, budget and scope).
This role requires collaboration within a matrix environment, proactive internal/external communication, and exceptional strategic planning, risk management and organizational skills.
Education / Qualifications
University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology)
In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
Thorough understanding of the drug development process.
Minimum of five (5) years of relevant clinical research experience with an ability to demonstrate comprehensive understanding of:
Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;
Site monitoring and study site management requirements;
Applicable regional regulatory requirements;
Trip report review, risk planning, study plan development, resource planning and data management oversight.
+candidates with> two (2) years supervisory experience in a health care setting and four ( 4) years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered.
Job Number 2018-25185
Job Category Clinical Trial Management
Position Type Full-Time
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