Senior Manager, Clinical Programming

Dyne Therapeutics•Waltham, MA

10d•Onsite

About The Position

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.

Requirements

6+ years of experience clinical programming with a focus on clinical data management and analysis within the pharma/biotech industry
Bachelor’s degree in life science or related discipline required, advanced degree preferred
Has in-depth knowledge of clinical database design, data standards, and data output programming expertise
Demonstrates ability to anticipate internal business challenges and successfully drives towards the best solution for the organization
Ability to perform short term tactical planning, typically for a 6-month horizon
Able to work in a highly matrixed, fast-paced environment with changing priorities and deadlines
Highly organized and detail oriented
Demonstrates strong collaboration skills with external service providers and cross-functional teams
Experience with project management and meeting facilitation skills
Able to manage time effectively and prioritize
GCP knowledge
Demonstrated experience in writing professional correspondence and clinical study documentation
Data modeling, listing, and visualization development experience with elluminate
EDC experience in various EDC systems, e.g., Medidata Rave
SAS programming experience a plus
Strong working knowledge of CDISC Standards (CDASH, SDTM, ADaM)
Strong understanding of clinical trial data
Strong communication skills both verbal and written, with the ability to collaborate effectively with diverse teams
Excellent problem-solving abilities and attention to detail

Responsibilities

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 technologies and methodologies relevant to the role