Manager/Sr. Manager, Clinical Operations

What’s the opportunity? \u003cp LifeMine Therapeutics is seeking an experienced and results-driven Manager/Sr Manager, Clinical Operations to join our growing Clinical Development team. Reporting to the Director of Clinical Operations, this individual will play a key role in the planning, execution, and management of clinical trials, ensuring successful delivery on time and within budget, while adhering to regulatory requirements and company objectives. The Manager/Sr Manager will work cross-functionally with R&D and external vendors, providing leadership and oversight throughout the clinical development lifecycle.\u003ch3>Key Responsibilities:\u003c/h3>\u003cul>\u003cli Manage the execution of clinical trials, ensuring that trials are conducted according to the highest standards, in compliance with Good Clinical Practices (GCP), and within timelines and budget.\u003c/li>\u003cli Provide strategic oversight and direction for clinical operations, ensuring alignment with corporate objectives and regulatory requirements.\u003c/li>\u003cli Oversee the operational aspects of clinical studies, including protocol development, site selection, contract negotiations, vendor management, monitoring activities, and data collection.\u003c/li>\u003cli Set-up and update clinical trial-related trackers such as startup progress, screening/enrollment, study invoices/payments, etc.\u003c/li>\u003cli Work closely with cross-functional teams to ensure smooth integration of all clinical operations activities.\u003c/li>\u003cli Ensure timely preparation and submission of clinical trial-related documentation to regulatory agencies and ethics committees.\u003c/li>\u003cli Develop and implement clinical trial processes, including risk management strategies, monitoring plans, and quality assurance initiatives.\u003c/li>\u003cli Track and report on clinical trial progress, identifying and addressing any issues or risks that could impact trial milestones.\u003c/li>\u003cli Act as a liaison between external vendors, sites, and LifeMine leadership to ensure effective communication and timely decision-making.\u003c/li>\u003cli Stay up-to-date with industry trends, regulatory changes, and clinical trial best practices to drive continuous improvement within the organization.\u003c/li>\u003c/ul>\u003c h3>What you will need to be successful:\u003c/h3>\u003cul>\u003cli Bachelor’s or Master’s degree in Life Sciences or a related field\u003c/li>\u003cli Minimum of 3 (Manager)/ 5 (Sr. Manager) years of experience in clinical operations within the pharmaceutical or biotechnology industry.\u003c/li>\u003cli Strong knowledge of clinical trial design, execution, and regulatory requirements (FDA, EMA, ICH-GCP).\u003c/li>\u003cli Proven track record of managing multi-site, complex clinical trials from start-up to completion.\u003c/li>\u003cli Experience working with CROs, vendors, and clinical trial sites, including contract negotiation and performance oversight.\u003c/li>\u003cli Excellent organizational, leadership, and communication skills with the ability to manage cross-functional teams effectively.\u003c/li>\u003cli Strong problem-solving skills, with the ability to identify and address challenges in a fast-paced, dynamic environment.\u003c/li>\u003cli Ability to manage multiple priorities and deadlines, while maintaining a high level of attention to detail.\u003c/li>\u003cli Proficiency in clinical trial management systems (CTMS) and other relevant software tools.\u003c/li>\u003cli Ability to travel as needed for site visits, meetings, and other clinical operations activities.\u003c/li>\u003c/ul> #J-18808-Ljbffr Socket.dev