Clinical Trial Manager, Clinical Development Operations (Hybrid)

Please note, this is a hybrid role.  We are not considering remote candidates at this time.

Omega Therapeutics is a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines to treat or cure a broad range of diseases. By pre-transcriptionally modulating gene expression, Omega’s approach enables precision epigenomic control of nearly all human genes, including historically undruggable and difficult-to-treat targets, without altering native nucleic acid sequences. Founded in 2017 by Flagship Pioneering following breakthrough research by world-renowned experts in the field of epigenetics, Omega is led by a seasoned and accomplished leadership team with a track record of innovation and operational excellence. The Company is committed to revolutionizing genomic medicine and has a diverse pipeline of therapeutic candidates derived from its OMEGA platform spanning oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.

About the Role:

Omega Therapeutics, Inc. is seeking a Clinical Trial Manager, 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 provide operational leadership and expertise in the implementation of clinical trials.  In conjunction with the cross-functional project team, the Clinical Trial Manager is responsible for overseeing the coordination, management and operational aspects of clinical trials  to ensure successful completion and ensure delivery of company goals on time, within budget, and in compliance with SOPs, Regulatory Authorities and ICH/GCP guidelines.  The position offers the opportunity to interact with all levels of management at Omega, peers and leaders from academic centers involved in key collaborations, external stakeholders in the medical and scientific community. 

Key Responsibilities:

• Oversees and monitors the management of a clinical trial, ensuring it is conducted in accordance with the approved study plans
• Leads the study team to execute the clinical trial in accordance with the clinical development plan/strategy and timelines
• Manages and/or assists in the oversight of CRO activities and other clinical vendors to ensure the quality meets Omega Therapeutics and regulatory requirements
• Provides day to day oversight of global clinical trial sites
• Lead and/or collaborate in the development of  study plans and other documents/materials required for study conduct
• May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance
• Reviews clinical monitoring reports and correspondence related to monitoring visits

Required Skills:

• Strong knowledge of applicable computer and project management software and tools
• Requires strong attention to detail and the ability to establish priorities, schedule, and meet deadlines
• Ability to work successfully within a cross-functional team and a matrix organization
• Excellent written and oral communication skills
• Ability to interact with invesigators, vendors, and internal colleages
• Knowledge of current regulatory requirements and guidelines governing clinical research
• Ability to manage and communicate effectively with research vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints
• Must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands
• Ability to complete tasks to deadlines and resolve/elevate problems in a timely manner under limited direction and on own initiative
• Strong communication skills, professional presence, and ability to engage effectively with stakeholders at all levels
• Collaborative and able to motivate and energize cross functional team members to achieve aggressive goals

 Required Qualifications:

• Bachelor’s degree or nursing qualification in a scientific field of study with 4+ years of relevant experience within pharmaceutical/biotech industry working in Clinical Operations in the Pharmaceutical/ Biotech industry or a CRO
• Excellent working knowledge of FDA & ICH/GCP regulations and guidelines and experience in clinical operations groups
• “Hands-on” ability to think strategically and tactically
• Knowledge and experience with managing vendors and clinical trial sites
• Strong knowledge of applicable computer and project management software packages
• Available for up to 25% domestic and/or international travel