Clinical Project Leader - CPL
Ray -
Dokki, GizaPosted 5 years ago46Applicants for1 open position
- 8Viewed
- 0In Consideration
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Job Details
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Job Description
- 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
Job Requirements
- 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.
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