Associate Director, Clinical Operations Study Lead

Role Summary:

The Clinical Operations Study Lead 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 ad SOPs.  

This individual may be responsible for one highly complex or multiple medium complexity clinical studies. This role is expected to require up to 20% travel, including international travel.   

This role is based in Waltham, MA. 

Primary Responsibilities Include: 

• Manage 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 
• Develop study level operational strategy and clinical operations plans in support of execution of the Program-level objectives/CDP 
• 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 
• Lead 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 
• Responsible for 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 (financial, project, etc.) for senior management on program status and issues as required 
• Provide management, oversight, coaching, mentoring,