Clinical Project Manager - MENA
Title : Clinical Project Manager
Location : Lebanon-Egypt
• 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).