Description:
Y-mAbs seeks a highly skilled Senior Manager, Clinical Operations & Data Management to join our radiopharmaceuticals team and will work closely 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.
Key Responsibilities
Data Management
- Oversee the design and maintenance of data flow for multi-site clinical trials to enable seamless data access.
- Partner with stakeholders to triage and mitigate issues and risks associated with clinical trial data management
Document management
- Utilize expert knowledge on the Trial Master File (TMF) Reference Model and eTMF to efficiently set-up, retrieve, and file trial documents. Review clinical data for completeness, accuracy, and consistency in accordance with the investigational plan.
Collaboration & Communication
- Foster cross-functional collaboration with internal teams and external partners (CROs, vendors, clinical trial sites) to achieve data goals. Ensure clear and transparent communication regarding data and documentation challenges and milestones.
- Serves as a liaison between the Clinical Operations (ClinOps) team and Contract Research Organization (CRO) for administrative tasks.
Vendor Engagement
- Represent Sponsor involvement with the CRO’s Data and Document Management team to ensure timely, accurate deliverables.
Quality Assurance & Regulatory Affairs
- Ensure studies adhere to applicable regulations and the Quality Management System for data and document management.
- Support the development and periodic review of Data and Document Management SOPs, WIs, and templates
Key Qualifications
- BSc in Medical, Biological, Pharmaceutical (or equivalent) Sciences. The candidate must retain a working knowledge in the principles of biomedical science, pharmaceutical development, and clinical research.
- Minimum 3 years of experience for a Sponsor or CRO, preferably in both corporate and start-up environments. Early phase (1/2) clinical trial experience required; pivotal clinical trial experience through NDA (or equivalent) preferred. Additional preference is given to candidates with experience in radiopharmaceuticals or oncology clinical trial experience.
- Experience with data management in a clinical trial environment.
- Knowledge of clinical trial operations, ICH-GCP, regulatory (FDA preferred) requirements, and clinical trial management. Experience with cross-functional teams.
- Travel: Up to 30%.