Clinical Trial Manager

Clinical Trial Manager

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.

The Clinical Trial Manager ensures that clinical strategies are translated into operational plans and executed in line with clinical development plans (CDPs). This position is responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives including aligning operational execution activities with agreed upon project priorities, timing, budget, and quality requirements. This position ensures study conduct adheres to all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Dyne's policies and SOPs. This individual may be responsible for one medium complexity or multiple lower complexity clinical studies. This role may also support management of certain aspects of one or more high complexity studies led by a Clinical Study Lead.

This role is based in Waltham, MA without the possibility of being a remote role.

Primary Responsibilities Include :

• Manage, either independently or in partnership with COSL, all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance applicable SOPs, guidelines and regulations
• Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
• Support the selection, oversight, and management of CROs and other vendors
• Monitor and assess vendor performance against contractual operational deliverables.
• Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors
• Provide oversight of study scope, quality, timelines and budget with the internal Dyne functional leads, CRO and vendors to ensure project objectives remain on track
• Participate in cross-functional teams and manage study team in partnership with the CRO
• Participate in a site engagement program to builds solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities
• Participate in planning and conducting investigator meetings together with the CRO
• Partner with the CRO to ensure patient enrollment strategies are carried out effectively and on time
• Coordinate and participate in proactive data monitoring activities to ensure quality and completeness of study data
• Evaluate issues, interpret data, and suggest and implement solutions and mitigation as required
• Create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances
• 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
• Provide ongoing oversight, maintenance and evaluate completeness of the TMF by performing periodic QC reviews to ensures the TMF and study is always "inspection ready"
• Prepare high-quality reports and dashboards (financial, project, etc.) for senior management on program status and issues as required

Education and Skills Requirements :

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.