.Job Purpose As a Manager Clinical Operations you are responsible for the management of all aspects of the Clinical Study Team activities for assigned clinical studies. You will work in concert with the Director Clinical Operations, and are accountable for achieving successful execution and delivery of MoonLake´s clinical development team activities at the study level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.Key Accountabilities: To lead the clinical study team tasked with delivery of MoonLake sponsored studies To assist in the selection of appropriate vendors for the conduct of MoonLake sponsored studies Ensure a detailed project plan is in place for the studies and work with the CRO and MoonLake team to set priorities and manage timelines Responsible for oversight of assigned clinical studies ensuring they are conducted in compliance with the protocol, study plans, relevant guidelines and contracts through regular vendor and/or investigator site contact. To perform accompanied site/vendor visits as part of Sponsor oversight Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and escalate to the Director Clinical Operations, when appropriate Monitor the status of clinical data collection of assigned clinical studies To develop/review study management plans ensuring Sponsor oversight of clinical studies in accordance with MoonLake procedures To review vendor generated clinical study related documents to ensure compliance with the objectives of the study, MoonLake procedures and relevant standards To act as the key contact for study associated vendors and ensure timely and effective communication between involved parties Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements To ensure essential documents allowing the reconstruction of each study are generated, filed and maintained by or on behalf of MoonLake. To communicate progress and identify risks and issues arising on the assigned clinical studies to the Director Clinical Operations and other MoonLake development project team members as appropriate. To ensure compliance with MoonLake procedures and SOPs. Help train/mentor more junior clinical operations team members, as required. Participate in the preparation, review, updating and training of SOPs and may serve as clinical operations representative for internal process/system development. Your profile Education: Bachelor's degree in Life Sciences, Nursing or other health care professional equivalent.Experience: Minimum of 5 years of clinical operations experience; with increasing levels of responsibility.Skills/knowledge/behavioural competencies: 5+years of clinical project management experience on the sponsor side. Substantial experience of managing outsourced global clinical studies
