- Develop and maintain good working relationships with company clients as well as investigators and study staff
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study specific manuals and procedures
- Negotiate and manage the budget and payments for investigative sites, if applicable
- Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
- Oversee performance of third party vendors and field CRAs including co-monitoring
- Collaboration with major functional areas to identify and evaluate fundamental issues on the project, interpret data, make good business decisions and ensure the implementation of timely solutions
- Accountability for ensuring all project deliverables meet customers' expectations
- Understanding scope of work, financial aspects of the project, expected project performance and strategies involved e.g. patient recruitment
- Attendance at Clinical Project Team set up meetings with the sponsor
- Attendance at Clinical Project Team routine meetings with the sponsor
- Being aware of communication channels per each assigned project for quick escalation of issues Planning the assignment of projects to CRAs based on clear understanding of their FTE status and pipeline projects\Proven experience in leading a global clinical trial, including the establishment of center
Has the ability to initiate processes independently, set goals and tasks in accordance with the goals of the experiment.
In-depth understanding of GCP principles
High interpersonal ability, both for team management and for a high level of customer service.
Ability to establish the required research systems in collaboration with professional service providers.
A desire to integrate into a dynamic society.
Immediate availability - an advantage
Excellent communication skills in English, written and spoken.
Powerful internal engine and aiming.