Clinical Operations Manager

Há 4 dias


Porto, Porto, Portugal Moonlake Immunotherapeutics Tempo inteiro

Job Title: Clinical Operations Manager

Job Summary:
As a Clinical Operations Manager at Moonlake Immunotherapeutics, you will be 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 Responsibilities:
Lead the clinical study team tasked with delivery of Moonlake sponsored studies
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
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
Develop/review study management plans ensuring Sponsor oversight of clinical studies in accordance with Moonlake procedures
Review vendor generated clinical study related documents to ensure compliance with the objectives of the study, Moonlake procedures and relevant standards
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
Ensure essential documents allowing the reconstruction of each study are generated, filed and maintained by or on behalf of Moonlake
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
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

Requirements:
Bachelor's degree in Life Sciences, Nursing or other health care professional equivalent
Minimum of 5 years of clinical operations experience; with increasing levels of responsibility
5+ years of clinical project management experience on the sponsor side
Substantial experience of managing outsourced global clinical studies



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