What are the responsibilities and job description for the Clinical Trial Manager position at Y-mAbs Therapeutics, Inc.?
Overview
The Clinical Project Manager, Clinical Operations, Radiopharma BU will work with other Clinical Trial team members, as well as cross-functional team members (CMC, Clinical Development, Statistics, etc.), to ensure operational expertise across one or more US-based clinical studies (diagnostic and therapeutic) with potential for global expansion, in accordance with applicable clinical trial standards and regulations, including ICH / GCP.
This role requires experience in clinical operations, project management, vendor management, and scientific collaboration, with a focus on ensuring the successful execution of clinical trials, optimal trial delivery, and maintaining a strong sponsor-CRO-site relationship. This role may include supervision of Clinical Trial Associates and CROs or other vendors as the organization grows. The Clinical Project Manager, Clinical Operations will work within a quality-focused organization and strive for continuous process improvement.
This position is part of the Radiopharma Business Unit and is located in the US.
Requirements
Clinical Trial Oversight : Support the execution of one or more radiopharmaceutical-focused (therapeutic and diagnostic) clinical trials by ensuring they are conducted in accordance with project timelines, budgets, and quality / regulatory standards.
Collaboration & Communication : Foster cross-functional collaboration with internal teams and external partners (CROs, vendors, clinical trial sites) to achieve trial goals. Ensure clear and transparent communication regarding trial progress, challenges, and milestones.
Project Management & Oversight : Provide project management oversight for all stages of the clinical trial lifecycle (from start-up to close-out) while ensuring compliance with regulatory requirements and internal SOPs. Track clinical trial metrics, including recruitment / enrollment activities, site monitoring / data entry issues, etc. and flag known risks to management.
Vendor & CRO Management : Responsible for day-to-day management of vendors, including budgets, contracts, etc. to ensure vendors are meeting scope of work to timelines.
Clinical Trial Documentation & Reporting : Support the production, review, and approval of clinical trial documents (e.g., protocols, informed consent forms, and clinical study reports).
Maintain complete and accurate trial documentation in compliance with Good Clinical Practice (GCP).
Site Relationship Management : Perform site visits as needed to ensure the effective management of clinical trial sites and to foster strong relationships with investigators and site staff.
Team Development & Training : Provide training on documentation as needed to internal and external stakeholders (including CRO personnel) ensuring they are adequately trained in trial responsibilities. Foster a collaborative and learning environment within the team. Train and mentor CTAs as needed.
Continuous Improvement & Best Practices : Contribute to the development and implementation of best practices within Clinical Operations. Encourage sharing of knowledge and lessons learned across trials and departments. Provide input to improve operational efficiency, quality, and effectiveness.
Quality Assurance & Regulatory Affairs : Ensure studies adhere to applicable regulations and the Quality Management System.
Key Competencies & Requirements
Education & Experience : BSc or MSc (preferred) in Medical, Biological, Pharmaceutical Sciences, or equivalent. Minimum 3 years of experience in executing clinical trials within the pharmaceutical or biotechnology industry. At least 1 years of project management experience in clinical research. Radiopharmaceutical clinical trial experience preferred.
Expertise : Knowledge of clinical trial operations, GCP, regulatory requirements, and clinical trial management. Experience with cross-functional teams.
Skills : Strong project management skills with an entrepreneurial mindset; ability to prioritize and work effectively in a dynamic, fast-paced environment. Proficiency with clinical trial management systems (CTMS), eTMF, and other relevant clinical research technologies. Exceptional communication, interpersonal, and leadership skills. Ability to build strong relationships with internal and external stakeholders. Proficiency with problem-solving and a results-oriented approach.
Attributes : High degree of initiative, proactivity, and flexibility to adjust to evolving clinical trial needs. Willingness and ability to mentor and develop junior team members. The ability to thrive in an organization that values innovation, adaptability, and a commitment to delivering meaningful results for patients.
Desired Characteristics : Proven track record of working on complex, multi-site clinical trials. Ability to handle ambitious timelines and work effectively with cross-functional teams. Experience working with radiopharmaceutical clinical trials is a plus. Knowledge of industry trends, emerging clinical trial technologies, and innovative methodologies.
Travel : Up to 30%.
Why Join Us?
As part of our Clinical Operations team, you will have the opportunity to make a direct impact on the development of life-changing treatments for cancer patients. We offer a dynamic, fast-paced work environment where innovation, collaboration, and continuous improvement are at the forefront. You will be part of a passionate team committed to transforming the lives of patients and their families.
For more information please see our web site regarding the company and our development projects.
