Senior Manager, Clinical Programming

Company Overview:

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.  Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.  

Role Summary:

The Senior Manager, Clinical Programming is responsible for overseeing and managing programming activities related to clinical trial data. The person in this role will ensure high-quality management of clinical trial data through effective programming strategies, driving best practices in programming, and ensuring that all clinical data is captured, processed, and reported to meet regulatory expectations and internal standards. This role collaborates closely with cross-functional teams, including clinical operations, biostatistics, and data management, to facilitate the successful execution of clinical trials. The person in this role leverages their expertise in programing and data management to create robust analytical databases, support regulatory submissions, and contribute to clinical study reports that showcase the efficacy and safety of our therapies. 

This role leads Clinical Programming projects and initiatives by navigating complex problems in support of Electronic Data Capture (EDC), external data handling, and data visualization.  This role performs programming tasks from study start-up to close-out according to the Standard Operating Procedures (SOPs), International Council for Harmonisation - Good Clinical Practice (ICH-GCP), and all applicable regulatory requirements.  

This role is based in Waltham, MA. 

Primary Responsibilities Include: 

• Oversee assigned day-to-day clinical programming activities, timelines, and deliverables for assigned projects 
• Collaborate with clinical operations, biostatistics, and data management teams to develop project timelines and ensure alignment of programming deliverables with clinical study objectives 
• Monitor project progress, identify potential issues, and implement solutions to mitigate risks 
• Provide technical and business expertise in support of data deliverables 
• Ensure compliance with internal polices, SOPs, and Work Instructions as well as external regulatory requirements related to clinical data management and programming  
• Conduct quality checks and audits of programming deliverables to guarantee accuracy and integrity 
• Identify opportunities for process improvements within clinical programming and data management practices and implement changes to enhance efficiency and quality 
• Effectively interact with vendors 
• Anticipate internal business challenges and successfully drive towards the best solution for the organization 
• Participate in effective planning and execution of programming tasks  
• Ensure timeliness and quality of data report deliverables in collaboration with Clinical Data Management team members and cross-functional colleagues 
• Enable consistent programming approaches, standards adoption, and best practices 
• Work closely with stakeholders to support data analysis and reporting needs 
• Participate in initiatives around process development, standardization, and technology 
• Contributes to selection and use of complex programming solutions to enhance clinical data collection and reporting 
• Provide oversight of programming tasks performed by third-party vendors and data management Contract Research Organizations (CROs) as assigned 
• Stay current with emerging technologi