Our Purpose: Empower Cells to Change Lives
At SQZ Biotechnologies (NYSE: SQZ) 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.
The Clinical Trial Manager (CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing. Strong vendor management of external vendors and CROs is critical for this role. The position may report to the Director, Clinical Operations. This role may work collaboratively on one trial or across several trials to support clinical operations activities.
- Perform day to day management and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases of trial
- Lead the Clinical Trial Team, and support other development teams as a Clinical Operations representative as required
- Perform and document study level Sponsor Oversight of outsourced clinical activities
- Communicate study-status, cost and issues to ensure timely decision-making by senior management
- Initiate and manage study-level timelines, including communication to internal and external team members on deliverables
- Work closely with other supporting clinical operations team members, if applicable, to execute clinical studies
- Draft and/or oversee the drafting of site materials including training, manuals and support documentation
- Review clinical data to ensure timely entry and readiness for data review meetings
- Perform periodic review of clinical data, quality metrics and study deviations
- Manage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
- Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
- Review clinical monitoring reports to ensure timely completion and identification of issues
- Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
- Complete and maintain internal clinical trial metrics, dashboards and other internal updates
- Ensure trial is conducted in accordance with SQZ and ICH/GCP standards including multiple regions in global trials
- Participate in testing of clinical trial systems/databases (i.e., UAT)
- Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
- May support additional clinical trial(s) in various capacities (e.g., unblinded clinical trial manager, regional clinical trial manager, etc.)
- Participate in clinical operations workstreams related to departmental and operating model related initiatives. Develop and maintain strong, collaborative relationships with key stakeholders within and external to SQZ
- Strive for continuous improvement and more efficient ways of working in clinical operations
- 5+ years of experience in a clinical research and industry environment, including a minimum of 2+ years of independent trial management preferred
- Bachelor’s degree required; Advanced degree preferred
- Relevant experience in global setting, across more than one phase of development, and across entire lifecycle of a study
- Solid understanding of drug development
- Ability to prioritize deadlines with excellent time management skills
- Good project management skills
- Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Excellent verbal and written communication skills
- Good organizational skills and attention to detail
- Must be able to handle multiple tasks/projects and manage priorities accordingly
- Self-directed with a demonstrated ability to work in collaboration and cooperation with members of a multidisciplinary team
- Experience managing outside vendors, e.g., CROs and other vendors
- Experience with U.S. and Ex-U.S. clinical trial management and Regulatory processes preferred
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.