Istanbul, Istanbul, Türkiye
Clinical trials, Pharmaceutical industry, clinical research, oncology, diabetes, growth hormon deficiency, CTMS, inform, IWRS, IVRS, site initiation, site closeout, site monitoring visits, GCP, pediatric trials, lung cancer, breast cancer, audit, inspection readiness, Risk Based Monitoring, IMPACT, eTMF, archiving, project management, line management
-Be a change agent for the project and gain support for the project within own function through communication of its aims and the positive impact it will have on the function -As needed input into general or specific communication material to make sure it makes sense to the function -Make colleagues from the function aware of the input required by the project and as appropriate give people the chance to engage and provide their opinions -Deliver an assessment of the work needed to support function in moving from the current ‘as-is’ ways of working to the future state -Coordinating across TAs and Phases to ensure all relevant functions provide feedback into this work -Evaluating key stakeholders across the groups and setting up a plan for active engagement with them -Setting up as needed SME networks into the relevant groups to facilitate finding out required information, for example Process, ‘use cases’ and Metrics information -Inputting into plans around collecting, combining and evaluating the required information -Inputting into the ‘Request for Proposal’ of vendor solutions to ensure your function’s requirements are represented -Evaluating vendor solutions as required and inputting into final decisions -Ensuring the success of the project by being collaborative, flexible, adaptive, proactive and sharing ideas and concerns with the group
Primary Monitor who directly communicates with regional project managers for country issues Site feasibility and selection activities Recruitment and Retention overall country follow-up Site Management Budget preparation Regulatory Authority and Ethics Committee communication and submissions of all types Site initiation/monitoring/closure visits Site activation Subject Matter Expert on TMF Meeting and Training Organisations for trials
Site Management Site contracts preparation Regulatory Authority and Ethics Committee Submissions of all types Site selection/initiation/monitoring/closure visits Site activation Subject Matter Expert on TMF
• Assisting & reporting to the Regional Regulatory Affairs Manager • Support all daily RA activities in the region to ensure in-time submissions of variation files to Health Authorities. • Preparation & compiling of labeling update variations • Follow up on MoHs requests and liaise with Head quarter in Denmark to prepare the responses accordingly • Support in preparing the pricing documents • Compile & prepare renewal files for the registered products as per the local regulations. • Prepare manufacturing sites registration & GMP files. • Archive all relevant RA files both physically & electronically according to archiving SOPs