Title: Clinical Project Manager
- Scientific background is mandatory
- Minimum of 6 years’ experience in the clinical research field includes monitoring activities, study feasibilities and ability to apply applicable regulatory guidelines.
- Strong written and verbal communication skills including sufficient fluency in English required
- Successful track record of managing at least 3 different projects
- Effective time management skills with ability to set priorities
- Coordination and control over the feasibility, start-up, clinical and site-management activities related to a specific clinical trial within the Department;
- Strict control over the compliance of study milestones: start, patients’ enrolment (overall study) and timelines as per the contract obligations
- Control over budget, issue, task and time management of the project/s under his/her supervision.
- Communication with sponsors, partnering CROs, physicians, or regulatory authorities.
- Initiate selection and approval, ongoing management and dealing with all third parties involved in the study.
- Identify changes, work with team members to quantify financial / time impact and communicate those changes to appropriate personnel.
- Control of submission/ approval process to EC/ RA in close collaboration with the clinical research associates.
- Organization and performing of study team trainings, meetings and customization of study-specific forms.
- Develop Study Specific plans as Project Plan, Monitoring Plan, TMF maintenance plan, communication plan, quality plan, project risk matrix (if applicable).