Role:
Contribute to the study protocol outline (ie ensure operational aspects are realistic and feasible) and budget development. Assess & pronounce on clinical site(s) & staff's suitability to conduct the protocol. Secure stakeholders agreement with the assessment outcome.
Lead and co-ordinate all activities to operationalise the study protocol, in an independent fashion, leading to the delivery of clinical trial statistical report according to the agreed Clinical Development Unit baseline timeline.
Conduct all operational activities according to internal SOPs & ICH GCP guidelines to ensure and document quality of collected data.
Track & manage study contracts to provide timely and accurate input into financial management systems and so delivering study to agreed budget. Reporting on budget to concerned SBU or business Project Manager.
Prepare, review & quality control essential study documents and collate all in Trial Master File. TMF documents collectively demonstrate adherence to ICH GCP guidelines and applicable laws. Required in case of inspection by national regulatory bodies or audit by IRB/EC or others.
Ensure trial subject protection.
Contribute to continuous improvement of working processes.
Requirements:
Bachelor Degree with a minimum of 4-5 years clinical project management experience in Food/Pharma/CRO industry.
Experience in leading & coordinating the activities of cross-functional operational teams and communication with internal & external trial stakeholders.
Experience in preparing and/or reviewing essential trial documents, maintenance of Trial Master Files and managing EC approval process.
Budget and contract management.
Vendor and clinical site selection, oversight and management.
Co-ordination of investigational product preparation, logistics and management of supply throughout trial. Management of biological sample logistics.
Experience in working with clinical sites to execute protocols.
Management & coaching of CRAs and other clinical trial personnel.
Experience of managing multi-site, international clinical studies.
Experience of risk assessment, implementation of mitigation plans and continous review and adjust to plans as required.
Ability to convince, negotiate with and manage the expectations of key clinical trial stakeholders including business/NRC project manager colleagues, the internal medical development team and external KOLs and their teams.
