Senior Manager

Description:

Y-mAbs Therapeutics is an innovative biopharmaceutical company focused on developing better and safer radioimmunotherapy and antibody-based oncology products targeting unmet pediatric and adult medical needs. The Senior Manager will lead Clinical Operations and Data Management activities for US-based clinical studies with potential global expansion. The role involves overseeing data flow design for multi-site trials, managing data and document quality, collaborating cross-functionally with internal teams and external CROs/vendors, and ensuring compliance with clinical trial standards (ICH/GCP) and regulatory requirements (FDA preferred). This position supports radiopharmaceuticals and oncology clinical trials, with significant involvement in vendor management and quality assurance. Up to 30% travel is expected. The role offers hybrid working flexibility based in Princeton, NJ, but remote candidates will be considered.

Key Responsibilities:

• Design and maintain clinical trial data flow across sites for seamless access

• Partner with stakeholders to mitigate data management risks

• Manage Trial Master File (TMF) and electronic TMF (eTMF) documentation

• Collaborate internally and externally for clear communication on data/document milestones

• Liaise between Clinical Operations and CROs for administrative and operational alignment

• Ensure clinical trials comply with regulatory and quality management systems

• Support SOPs, work instructions, and template development for data/document management

• Participate in CMC project, clinical, and regulatory meetings

Key Qualifications:

• Bachelor’s degree in Medical, Biological, Pharmaceutical, or related Sciences

• 3+ years clinical trial data management experience in Sponsor or CRO, preferably with early phase and pivotal trials

• Knowledge of ICH-GCP, FDA regulations, clinical trial operations

• Experience with oncology or radiopharmaceutical clinical trials preferred

• Strong cross-functional teamwork and communication skills

• Ability to travel up to 30%

Equal Employment Opportunity:
Y-mAbs is an equal opportunity employer with a strong commitment to diversity, equity, and inclusion. Reasonable accommodations available for applicants with disabilities.