Clinical Trial Specialist

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

This position, reporting to the Clinical Trial Manager/Clinical Trial Director, will be based in Obour and hired under Legacy Amoun (part of Arcera) employment contract.

Main duties

• Serves as a primary operations contact for internal and external study team members on assigned local and global studies/projects
• Participation in update of the data base of vendor, including CRO
• Responsible for Good Documentation Practice of the study including Sponsor Trial Master File assuring compliance of clinical trials with SOPs and local regulations, ICH, and GCP guidelines.
• Assures protocol compliance and training of study personnel, participants and contracted vendors.
• Participates in preparation and submission of dossiers for clinical trial applications and clinical documentation in dossiers for new marketing authorizations based on defined regulatory strategy and timelines
• Coordinates and support with needed documents when third parties assigned for the submissions to independent ethics committees IECs) and institutional research boards when
• Acts as contact person for Clinical activities during Product Development, the Out-licensing Team, Business Development, Global Medical Affairs, PV, and external service providers on all types of new projects clinical trials activities
• Participates in due diligence of clinical and related medical documentation
• Participates in timely response to requests for supplementary information (deficiency letters) to clinical part from Regulatory Competent Authorities
• Assures data administration in internal clinical trials database
• Develops and maintains a thorough and up-to-date understanding of the clinical trials regulatory environment, pathways and supporting data requirements
• Evaluates and improves regulatory and clinical trials compliance
• Develops clinical knowledge and due diligence capabilities within the team
• Responsible for achieving assigned KPIs

Job Requirements

• Degree in biomedical sciences (Medicine/Pharmacy/Veterinary/Pharmaceutical Sciences/ Science) or Chemistry.
• Excellent communication skills, both verbal and written, with a passion for accuracy and attention to detail.
• Excellent interpersonal skills – ability to interact effectively with a diverse group of people from different functions, of different nationalities and at different levels within the company.
• Good written and oral knowledge of English.
• Skilled at leading non complex projects and clinical trials.
• Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities.
• Knowledge of pharmaceutical and clinical trials regulatory processes
• In depth knowledge of GCP guidelines, in particular related to the sponsor role of clinical trials.
• Understanding of Operational activities in clinical trials.
• Leads interactions with third party providers and consultants during all stages of the clinical (and preclinical if needed) clinical trial operational process.

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you