Ref #: 28189

Employment type: Permanent - Full-Time

Location: Belgium

Posted: 06-Apr-2021

Description

Key Responsibilities:

* Ensure regional/global clinical operations deliverables progress according to agree upon timelines and milestones as leader of the Study Management Team (SMT). This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set activities as assigned by the GTL
* Support GTL in leading related CRO country & site activities
* Study Management Team Leader
* Site selection, enrolment, monitor study progress
* Financial planning and tracking
* Document development
* Training and Investigator Meeting
* Cross functional Study Management
* Continuous Quality Focus
* Data Cleaning
* Participate in Global Clinical Development Initiatives as assigned.
* Can act as Subject Matter Expert


Required experience and qualifications:

* BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
* Minimum of 6 years clinical trial management experience in the pharmaceutical industry or CRO
* Experience with management and supervision of CROs/vendors is preferred.
* Clinical research operational knowledge, strong project planning/management and effective communication skills
* Languages required : Fluent Dutch & English
* Experience and ability in coordinating global or regional teams in a virtual environment. Proven track record in successfully managing various aspects of trials from start-up to database lock.
* Monitoring experience is recommended or other relevant experience should be considered, such as data management or central monitoring.
* Strong knowledge of standard Microsoft applications, willingness to learn new systems
* Experience with planning tools is an asset
* Willing to travel internationally up to 20% of time