Job expirat
Project manager - Job responsibilities :
Choose the experimental centers jointly with the CEO, the local monitors and the sponsor
Cooperate with the CEO in the evaluation of projects and plans
Evaluate the feasibility or implementation of the project under field conditions and propose changes to improve the chances of success
Coordinate the preparation of the material (protocol, CRF, investigator's brochure, operation manual, monitoring forms, hospital records, medication etc.)
Supervise and monitor the conduct of the clinical study
Cooperate with Data Management in controlling suitability and completeness of the data bases
report on a regular basis the progress of the project to the CEO with special regard to deviation from the original plans and to the remedial measures resorted to or suggested
Inform the CEO and the interested parties of any unforeseen circumstances that affect the progress of the project to an essential degree
Keep in close touch with the investigators and the monitors both by telephone and on site
Control and motivate the monitors
Define the need to audit centers or monitors
Provide appropriate assistance in case of external audit of relevant projects
QA manager - Job responsibilities :
Organisation of quality assurance system
Quality control (GCP, ISO if applicable), especially for protocols, CRFs, CTRs etc
Organisation and conducting of internal and external audits
Creation, maintenance, and supervision of quality assurance documents
Creation, maintenance, and supervision staffs CVs
Creation, maintenance and update of Standard Operation Procedures
Training of SOPs
Education:
• Scientific background: Degree in Medicine, Pharmacy or Sciences
• Experience in drug control might be an advantage. Also certain certifications.
Experience & knowledge:
• At least two years experience within a pharmaceutical company or CRO in similar position; understanding of health care system and of the regulatory, legal and financial implications of the business
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