About Omega Therapeutics:

Omega Therapeutics is a Clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming™ platform. The OMEGA™ platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth and differentiation to cell death. Using a suite of technologies, paired with Omega's process of systemic, rational and integrative drug design, the OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's engineered, modular, and programmable mRNA-encoded epigenetic medicines, Omega Epigenomic Controllers™, target specific intervention points amongst the thousands of mapped and validated proprietary and novel DNA-sequence-based epigenomic loci, EpiZips™ to durably tune single or multiple genes to treat and cure disease through Precision Genomic Control™. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.

About the Role:

Omega Therapeutics, Inc. is seeking a Clinical Trial Associate, to join our clinical team. This role will play a key role in advancing the near-term pipeline and contribute to future programs in various stages of development. The successful candidate will be responsible for multiple tasks that support Omega's clinical studies. The Clinical Trial Associate will play a key role and will work with the clinical study team to support activities required for the execution and ongoing conduct of investigational clinical studies in compliance with SOPs, Authorities and ICH/GCP guidelines.

Key Responsibilities:

• Responsible for coordination, tracking, and management of logistics in support of clinical trials
• Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical studies including review and approval of regulatory packages for release of clinical supply
• Reports study metrics and other critical information using study trackers, data forms, and reports
• Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines, etc.
• Responsible for set-up, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files; coordinates TMF transfer with CROs
• Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific study requests and issues
• Manages and coordinates logistics for clinical and non-clinical supplies
• Manages logistics and assists with the coordination of meetings
• Responsible for agendas and meeting minutes for clinical study team meetings

Required Skills:

• Understanding in relevant clinical operations activities
• Ability to exercise judgment within generally defined practices and policies that lead to methods or processes for obtaining results under supervision
• Basic knowledge and understanding of ICH/GCP guidelines and FDA regulations
• Working knowledge of TMF maintenance and management of essential documents
• Solid interpersonal, written, and verbal communication skills across study team including study management
• Strong knowledge of applicable computer and project management software and tools
• Attention to detail and accuracy in work
• Effective time management and organization skills
• Ability to multi-task under limited direction and on own initiative
• Performs other work-related duties as assigned

Required Qualifications:

• Bachelor's degree or equivalent degree in a scientific field of study, nursing qualification, or related field with 1-3 years of relevant experience within pharmaceutical/biotech industry, CRO and/or healthcare setting
• Knowledge of drug development, clinical operations processes, and documentation including study start-up procedures, maintenance phase, and study close-out procedures
• Working knowledge of regulatory documents and TMF maintenance
• Available for up to 25% domestic and/or international travel