Clinical Manager

The Clinical Manager is responsible for all aspects of the clinical trials for which they are assigned under the direction of the Clinical Operations Director (COD) and/or Clinical Operations Senior Director (COsD)This person is accountable for achieving successful delivery of Curium clinical trial activities by meeting Health Authority (FDA, EMEA, HS, etc.), company and regulatory requirements.

Work Schedule: Mon - Fri 8am-5pm

• Accountable for efficient execution of assigned clinical studies.
• In concert with the Clinical Operations Director and/or Clinical Operations Senior Director , Review and contribute to study Protocols, eCRF design and completion guidelines, laboratory manuals, Informed Consent Forms, and other study-related documents.
• Under the leadership of the Curium Clinical Operations Director and/or Clinical Operations Senior Director , participate in the Curium / CRO / Site team that defines, and executes the Clinical Study Management Plan.
• Collaborate with Key Opinion Leaders (KOLs) of the Curium organization to ensure their feedback is adequately integrated into protocols.
• Contribute to the development of clinical sections of regulatory documents like Investigators Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities' questions.
• Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CROs as applicable.
• In collaboration with the Clinical QA Coordinator, oversee monitoring activities at clinical CROs by reviewing visit reports, protocol deviations and EDC queries.
• Work with CROs to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives.
• Work with CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
• In collaboration with the Clinical Project Manager, perform financial management, including review and approval of site and vendor invoices, investigator contracts and site payments. And track and coordinate trial related materials, including clinical trial supplies and laboratory samples.
• Serve as a liaison and resource for investigational sites.
• Organize and manage internal team meetings and other trial-specific meetings.
• Other responsibilities as assigned.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Bachelor or Master Degree of equivalent in a scientific or health care field is required.
• Minimum of 5 or more years of relevant experience w/ 2 or more years of Clinical Trials Administration experience, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance.
• Strongly preferred experience in Nuclear Medicine diagnostic and therapeutic clinical trials.
• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, current Good Clinical Practice (cGCP), data methods and general pharmaceutical GXP.
• Experience in running a trial from start to finish is preferred.
• Experience in prospectively designing and implementing tactics to drive and improve clinical trial execution.
• Excellent verbal and written communication skills.
• Must be proficient in Microsoft Office tools.
• Dedicated organizational and time management skills are required.
• Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.
• Strong team orientation, with excellent written and oral communication skills and interpersonal skills.

Working Conditions:

• Standard office environment
• Willingness to work in a team-based environment
• Close attention to detail required
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require
• May be required to sit or stand for long periods of time while performing duties