Clinical Manager Position Available In Wake, North Carolina

Job Title:

Clinical Manager Job Description The Clinical Manager is responsible for overseeing all aspects of assigned clinical trials under the guidance of the Clinical Operations Director and/or Clinical Operations Senior Director. This role requires ensuring successful delivery of clinical trial activities in compliance with Health Authority and regulatory requirements. Responsibilities Efficient execution of assigned clinical studies. Review and contribute to study protocols, design, completion guidelines, laboratory manuals, Informed Consent Forms, and other study-related documents. Participate in defining and executing the Clinical Study Management Plan. Collaborate with Key Opinion Leaders to integrate their feedback into protocols. Contribute to the development of clinical sections of regulatory documents. Monitor study progress and ensure compliance with regulations and guidelines. Oversee monitoring activities at clinical CROs, reviewing visit reports and protocol deviations. Work with CROs to ensure patient enrollment and data collection align with study timelines. Revise scope of service agreements, budgets, plans, and detailed timelines with CROs. Perform financial management tasks, including reviewing and approving invoices and contracts. Serve as a liaison and resource for investigational sites. Organize and manage internal and trial-specific meetings. Maintain operational compliance with US and international regulatory agencies and guidelines. Essential Skills Minimum of 5 years of relevant experience with at least 2 years in Clinical Trials Administration. Experience in nuclear medicine diagnostic and therapeutic clinical trials is strongly preferred. Thorough knowledge of clinical research concepts, practices, FDA regulations, and ICH Guidelines. Experience in running a trial from start to finish. Proficiency in Microsoft Office tools. Excellent verbal and written communication skills. Strong organizational and time management skills. Ability to work effectively with minimal supervision. Strong team orientation and interpersonal skills. Additional Skills & Qualifications Experience in big pharma and vendor management (CROs, imaging vendors). Experience in oncology and patient recruitment is a plus. Experience in prospectively designing and implementing tactics to improve clinical trial execution. Work Environment The work environment offers a hybrid model with 3 days onsite and 2 days remote, or fully remote for the right candidate. There may be travel to sites, and flexibility in schedule is necessary for calls across different time zones, such as Europe.