Tasks & Responsibilities Accountable for operational management of clinical trials: planning, set up, conduct and reporting. As Leader of the Trial Team, maintains oversight, ensures feasibility of trial plans, and pro-actively assesses and mitigates risks. Enforces AAI (Agility, Accountability, Intrapreneurship) approach and skills in the trial team and trial management. Leads development of core trial documents (e.g.CTP, Integrated Risk Management Plan, and Patient facing documents). Supports clinical development and pharmacovigilance in assessment of risk-benefit profile Works with functional partners to ensure that all required trial processes are in place prior to trial initiation (e.g. safety monitoring, investigational medicinal product, trial budget, vendor selection) Aligns and supports team members in responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders Ensures provision/provides appropriate study-specific and medical training of the global trial team and external partners. Maintains oversight of clinical trial including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and Company Business Practices; continuous risk monitoring/mitigation and budget oversight; continuous benefit-risk monitoring, including regular medical and data quality review. Responsible for timely, complete and compliant archiving of all relevant global documents for the TMF Contribute to project and trial strategy Develop and maintain company relationships with external experts and investigational sites by coordinating and ensuring cross-functional collaboration amongst CD&O and Medical Affairs Requirements University degree in life sciences or related field, higher degree/qualification preferred (e.g. MSc, PhD).Major focus: Biomedical Life Sciences Understanding of the scientific and/or technical components of the clinical development process, and associated regulatory requirement Previous experience working within clinical trial management as a CTL or equivalent Strong and in-depth understanding of teamwork and high-performance teams Working in multi-cultural environment and in-depth understanding of corporate culture and cross-culture dynamics. Please apply on the Lifelancer platform at the below link for screening steps & quicker response. https://lifelancer.com/jobs/view/130c59dab08e7e2a13774a5ed9697747