Covance Clinical Team Lead in Israel
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. Are you ready for the next step in your career? We are currently recruiting for a Clinical Team Lead ready to join our constantly growing CoSource team. This is a full-time, permanent and office-based position at our Client’s office in Israel.
As a Clinical Team Lead you will act as a member of the Core Project Team and will have overall responsibility and accountability for the execution of the clinical operations strategy of the project. Clinical Team Lead is responsible for coordinating and managing the clinical operations team, providing operational leadership and expertise to ensure successful execution of the clinical operations project deliverables (quality, timeline, budget and scope).
This role involves regular and proactive communication with the Sponsor, the Project Manager/Project Director and other functional groups, as appropriate. The successful candidate will serve as the main site monitoring and site management contact and support for the Project Manager and the client.
Education / Qualifications
University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
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.
Working knowledge of Covance SOPs.
Experience as a Senior Clinical Research Associate, whether internal or external.
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.
In lieu of the above requirements, 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.
Additional requirements include:
Demonstrated ability to work with minimal supervision.
Demonstrated good planning and organization skills.
Good computer skills with good working knowledge of a range of computer packages.
Demonstrated effective and professional verbal and written communication skills.
Ability to train, lead and develop junior staff.
Ability to understand and work with financial information.
Ability to resolve project-related problems and prioritizes workload for self and team.
Ability to work collaboratively within a project team.
Ability to work efficiently and effectively in a matrix environment.
1+ year’s additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
Local project coordination and/or project management experience.
Thorough knowledge of Covance SOPs regarding site monitoring.
Job Number 2017-15413
Job Category Clinical Operations
Position Type Full-Time