Provides realistic timelines, states practical and valid operational models.
Provides strategic and tactical guidance in risk management taking into account the business interests.
Identification of project and clinical trial risks, creation of contingency/mitigation plans and solution implementation.
Assesses & pronounces on investigational site(s) & staff's suitability to conduct the protocol. Secures stakeholders agreement with the assessment outcomes. Select, manage and coordinate external vendors, such as Clinical Research Organization (CROs) and central laboratories.
Manage operational aspects of the clinical study. Ensures the delivery of the study according to ICH GCP and Clinical Development Unit (CDU) quality standards. Take daily decisions in the best interest of the business.
Proven experience in preparing and/or reviewing essential trial documents, maintenance of Trial Master Files and managing Regulatory/Ethical Committee submission process.
Budget management and reporting to concerned Strategic Business Unit (SBU) or business Project Manager.
Co-ordination of investigational product preparation, logistics and management of supply throughout trial as well as management of biological sample logistics.
University degree level or equivalent in related scientific field
Significant clinical project management experience in Food/Pharma/CRO industry or in an academic setting.
Proven experience in leading & coordinating the activities of cross-functional operational teams
Experience of working with clinical sites to execute protocols.
Experience of managing multi-sites, international clinical studies (including vendor and clinical site selection, oversight and management; budget and contracts management).
Experience in risk management
Excellent communication skills, ability to convince, negotiate with and manage the expectations of key clinical trial stakeholders.
Strong problem solving attitude and a creative mindset
Willingness to travel according to business needs (10-20%)