December, 10th

Clinical Operations Scientist

CO_1219
PREV. JOB

Role and Responsibilities

• Reports to Clinical Operations Manager

Responsible for:

• Coordination of Bioequivalence / Clinical studies
• Coordination of monitoring and auditing activities for clinical studies
• Review of Bioequivalence / Clinical study protocols and relevant documentation.
• Assessment of Bioequivalence / Clinical studies’ data
• Review of Bioequivalence / Clinical study reports / Dossier’s module 5 and module 2 deliverables
• Archiving and maintenance of Bioequivalence / Clinical studies related documentation
• Evaluation of the scientific literature related to the clinical aspects (pharmacokinetic and drug metabolism) of the generic pharmaceutical products under development

Experience & Qualification

• Education to a post-graduate degree level in Pharmacy, Pharmacology, Pharmacokinetics or similar scientific disciplines
• 1-2 years of experience in clinical operations of Generic Pharmaceutical Products will be preferred
• Knowledge of ICH and EMA clinical efficacy and safety guidelines and in particular the EMA guidelines for Investigation of bioequivalence and bioanalytical method validation
• Excellent English oral communication and scientific writing skills
• Knowledge of CTD Dossier Compilation is preferred
• Knowledge of medical writing
• Knowledge of basic pharmacokinetics
• Experience in the use of statistical/ pharmacokinetic software (for example SAS, WinNonlin etc.)

PharOS Ltd Offers

• The successful candidate will be remunerated with a competitive salary
• Private healthcare package
• Continuous training on all aspects of clinical efficacy and safety guidelines
• Challenging working environment

Please apply for this position by forwarding your CV in English to: PharOS Ltd, Lesvou Str. (end), Thesi Loggos, Industrial Zone | 14452, Metamorfossi Attikis, Greece, via e-mail at: cv@pharosgr.gr

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