Job DescriptionAre you ready to uplevel your career? Join an innovative biopharmaceutical company and be part of our exciting journey!
We are looking for a Senior Manager, Clinical Operations & Data Management, to join our team.
Working with Us
At Y-mAbs Therapeutics (NASDAQ: YMAB), our mission is to become the world leader in developing better and safer radioimmunotherapy and antibody-based oncology products addressing clear unmet pediatric and adult medical needs. With the right partnerships and collaborations, we envision changing the course of cancer treatment and improving outcomes for patients and their families.
We have offices in
Princeton, New Jersey (US) and
Hørsholm, Denmark (near Copenhagen). We also have a laboratory based in
Nutley, New Jersey (US).
Y-mAbs has an exciting future ahead. If you are passionate about being part of a truly patient-centric organization focused on developing and commercializing cutting-edge therapies to treat a variety of cancers, we want to hear from you!
About the Role
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%.
Participation in
- CMC project meetings
- Review of key manufacturing documentation
- Review of CMC documentation
- Clinical and regulatory meetings
Location
This role is based in our Princeton Office with a hybrid working pattern. We will also consider remote candidates.
Interested in Applying
If you are interested in joining Y-mAbs and becoming part of our team in a fast-moving environment that offers a unique combination of scientific insight, entrepreneurship, and exciting challenges, please apply!
Equal Employment Opportunity Statement
It is the policy of Y-mAbs to provide employment, training, compensation, promotion and other conditions of employment without regard to a person’s sex/gender, pregnancy (including childbirth, breastfeeding and related medical conditions), age, race, color, religion, creed, sexual orientation, gender identity, gender expression, genetic information, marital status, familial status, civil union or domestic partner status, nationality or national origin, ancestry, citizenship, immigrant status, military status, veteran status, handicap, physical or mental disability, use of a trained service animal, medical condition, atypical hereditary cellular or blood trait, victim of domestic violence crime, sexual assault or stalking or membership in any “protected group” under federal, state or local law. This policy applies to all conditions of employment including but not limited to recruitment, selection, placement, transfer, promotion, training, compensation, benefits and termination.
All decisions regarding conditions of employment must and will be based on the individual's overall qualifications and their ability to meet the requirements of the position. Applicants and employees with disabilities will be provided with reasonable accommodations, except where such accommodation would cause Y-mAbs undue hardship. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please contact Chris Naylor at cna@ymabs.com. Y-mAbs will use its utmost discretion in keeping such information confidential and shall disseminate such information only on a “need to know” basis only.
