Clinical Trial Manager
TCR² Therapeutics Inc. is an immuno-oncology company developing novel cancer therapies that unleash the full signaling power of complete T cell receptors (TCR). TCR² has developed a unique proprietary TRuC™ platform which can reprogram the natural TCR complex to recognize specific antigens found on tumors where they elicit rapid killing of cancer cells. The company has demonstrated activity against both hematological and solid tumor targets in preclinical models and believes its TRuC™-reprogrammed T cells will serve as the engine for important therapies. TCR² was founded by MPM Capital and has scientific operations in Cambridge, MA to leverage best-in-class technologies and nucleate top-tier academic laboratories around the world.
TCR² Therapeutics is building a clinical development team and is seeking talented and independent candidates to execute its clinical studies. The successful candidate will ensure TCR² Therapeutics’ clinical trial(s) are managed to the highest quality to ensure safety and effectiveness of TCR² Therapeutics’ products in adherence with regulations. The position is an excellent opportunity for career development as TCR² Therapeutics is in the midst of building out the infrastructure to support an innovative clinical pipeline and the candidate will have the opportunity to help shape the future of the organization.
Manages all clinical aspects of study, including: assesses operational feasibility and recommends study execution plans; manages study timelines and metrics; participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel; prepares and presents project debriefings, as required; plans, executes, and attends/manages study-specific meetings (e.g., Study Management Meetings, investigator meetings, etc.) as applicable; participates in site monitoring visits as appropriate.
Uses operational and therapeutic expertise to optimize trial design and execution: works with the study team to design clinical trial protocols and assists in developing/managing an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met; prepares study-related documentation; supports the creation of the ICF template, CRFs, etc.
Prepares and/or reviews study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, CRF Completion Guidelines, etc.).
Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
Selects sites and countries; develops relationships with investigators and site staff.
Assists in development and management of study budget and maintains it within financial goals; reviews and approves clinical invoices against approved budget.
Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate.
Interface with cross-functional teams (e.g. Medical Monitor, Regulatory Affairs, CRO, vendors and Investigators/site staff).
Manages clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.) ensuring compliance with ICH/GCP and applicable regulations. Includes management through resolution (CAPA) of any site or study level issues, deviations, etc.
Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
BS/BA/RN Degree in a life science or a health-related field is preferred, with a minimum of at least 3 years of managing multi-disciplinary project teams working on phase I-IV global clinical studies
Biopharmaceutical/Biotech experience strongly preferred
Experience and understanding of global clinical trial operations; preference in the oncology and/or cell therapy space
Excellent knowledge of ICH/GCP and regulatory requirements
Familiarity with clinical data review and data management processes, including Data Monitoring Committees
Prior experience supporting regulatory filings and inspections and audits desirable
Excellent and transparent communication skills and ability to influence across multiple functions
The ability to independently lead several projects simultaneously, an adaptive working style and a creative and thoughtful approach to problem solving
Thrives in a fast-paced and evolving environment
Must be able to travel up to 25%, domestically and internationally
Office-based position in Cambridge, MA
Interested candidates should send their resume to email@example.com