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My qualification includes strong educational background with doctor of medical technology and health sciences with substantial experience in coordinating, monitoring and managing Clinical Trials/Clinical Evaluations phases I to IV especially in areas of nephrology, cardiology, oncology, diabetology and metabolism.
As a Certified Project Manager Associate (focus on Clinical Trials/Clinical Evaluations), I have strong knowledge of conducting clinical studies backed by more than 10 years of experience doing clinical research. During this period, I have gained extensive knowledge of how to coordinate, perform and manage different clinical study activities initiated by industry sectors e.g. CROs, academic institutions e. g. universities in the USA and Germany, and start-up activities through their close-out. I am well acquainted with FDA, AMG, MPG, ICH-GCP, and GCP-V regulatory requirements, SOPs, quality standards, and managing resources and budgets.
Other activities but not limited to include acquisition of human use approval from Ethics Committees and Competent Authorities; reporting site enrollment progress; reviewing case report form; data collection; site monitoring (initiation visit through close-out visit); identifying and reporting adverse events; maintaining a close contact with all stakeholders (sponsor, regulatory authorities, study site staff, monitors, etc.) and develop new improved processes and perform implementation.
I believe that my current and past professional expertise, as well as my multicultural and multilingual background along with project management and problem solving skills make me a desirable candidate for such position.
I thank you for your professional courtesy in reviewing my job application. In addition, I am enclosing my curriculum vitae and qualification profile.
Please feel free to contact me at 0049 (0) 178 376 9284 or via email: [email protected].
Thank you very much for your time and consideration.
Sincerely
Developing, reviewing and editing of project plans according to study protocol
Responsibility over budget, deadlines, project handling and controlling
Monitor project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations
Coordination and negotiation with internal and external project partners (Stakeholder Management)
Excellent communication, planning, presentation and organizational skills as well as a team-oriented approach
Experience in quality management and quality assurance
Delivering project team training, development and performance review of assigned staff
Preparation and submission of dossiers including clinical trial applications and related documents for regulatory agency
Excellent analytical and problem solving abilities
Ability to lead and mentor project team members
Providing logistical support throughout entire project cycle
Good knowledge in statistics, data management and medical writing
Work on strategic concepts for continuous improvement
Strong working knowledge of guidelines, systems for clinical trial management and of ICH, FDA, GCP regulations and practices, ISO 14155 (Clinical investigation of medical devices for human subjects-GCP) and Corrective Action/Preventive Action (CAPA) concept.