Clinical Project Leader - CPL

Ray -
Dokki, GizaPosted 5 years ago

46Applicants for1 open position

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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 enrollment (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

Bachelor degree of medical background (Physician, Pharmacist).
Excellent knowledge of Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines.
Excellent knowledge of the national and regional regulations for conducting clinical trials.
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics.
Proven ability to understand customer needs.
Effective mentoring and training skills.
Ability to balance operational and strategic priorities.
Strong communication and interpersonal skills, including good command of English language, French is a plus.
Excellent presentation skills.
Demonstrated proficiency in using systems and technology to achieve work objectives.
Demonstrated proficiency at analyzing data and information to make conclusions and drive sound decision making.
Proficient with all computer applications such as Word, Excel, Outlook and PowerPoint.
More than 6 years of proven experience in the clinical research field and study management.
A minimum of 2-3 years of experience in a similar managerial position.
Occasional travel requirements.