Our Purpose: EMPOWER CELLS TO CHANGE LIVES
At SQZ Biotechnologies we believe that our cell therapies will revolutionize the way we treat diseases. Our unique capabilities enable us to engineer almost any function into any cell type, breaking down the barriers in the field, and creating the possibility for cell therapies that could not have been previously envisioned.
- Patients are the Purpose: We strive to transform patient quality of life so they can focus on living.
- Squeeze Together: We are one team with one goal. Only through the sum of our strengths can we achieve our shared purpose.
- Own the Outcome: We are what we do. Integrity and accountability are fundamental.
- Challenge the Now: We fearlessly drive innovation by questioning what is possible, fostering creativity, and executing on our ideas.
SQZ Biotechnologies is seeking a Senior Clinical Data Manager to join our Clinical Operations team. This is a newly created role and will report directly to Head of Clinical Operations. The selected applicant will be responsible for independently leading Data Management aspects of a clinical study. The Senior Clinical Data Manager has thorough knowledge of FDA regulations and industry standards, strong technical skills, and can work collaboratively with vendors to assure that Data Management functions are performed in compliance with regulations and according to study protocol.
- Develops/executes/reviews project documentation, including, but not limited to, Data Management Manual, eCRF Completion Guidelines, edit checks, query logic and work instructions for assigned projects. Designs and modifies eCRFs.
- Manages activities including: EDC Build and UAT, medical coding, developing data validation checks and managing database snapshot.
- Lead data reconciliation of electronic data transfers from vendor to Sponsor.
- Assist communication with database (DB) vendors on consistent basis to address Clinical teams requests and/or eCRF development activities.
- Provide Clinical Data Management support to cross-functional team.
- Participate in the review of Clinical research documents (e.g., Protocols).
- Participate in UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
- Participate in UAT of IxRS.
- Participate in the preparation and presentation of data, when applicable.
- Ensure the quality of clinical data to support study report, IND and NDA submissions meets standards.
- Facilitates the review of interim/final data listings prior to transmission to other groups or inclusion in regulatory submissions.
- Assist in the gathering of design requirements from stakeholders and organize in a standard format to address the needs of users (e.g., investigator, study coordinator, study monitor) and simplifies data collection and analysis.
- Support the identification, review, evaluation and implementation of new technologies related to clinical data standards.
- Ensure data management related SOPs are up-to-date and are FDA-compliant
- Manage the Clinical data management study budgets.
- Performs other functions as required or assigned (e.g., QC of CSRs, submission-related documents, etc).
- Bachelor’s degree in life science/biomedical/medical science with a working knowledge of the clinical/scientific terminology and methods common to the biopharmaceutical setting.
- Minimum of at least 7 years of relevant experience working in a clinical research environment within biotech/pharmaceutical/CRO preferred, with understanding of the clinical development and data management processes.
- Vendor management and selection experience.
- Proficient in clinical data collection and data management tools.
- Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Working knowledge of Clinical database applications such as EDC, CTMS and IxRS.
- Knowledge of MedDRA coding, CDISC standard, or SAS would be a plus but not mandatory.
- Intermediate knowledge of research and development activities with experience performing CRF Design activities in a clinical research environment.
- Knowledge in industry data standards and regulatory data submission requirements, with a focus on SDTM and electronic submission (eSub).
- Good verbal and written skills, good organizational, interpersonal, and team skills.
- Create solutions and present to stakeholders.
SQZ Biotechnologies is proud to be an equal opportunity employer and to provide equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, SQZ complies with applicable state and local laws governing nondiscrimination in employment. SQZ does not support relocation for this role.