Senior Manager, Clinical Programming

<div class="content-intro"><h3>Company Overview:</h3> <p>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 Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a 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 at <a href="https://www.dyne-tx.com/">https://www.dyne-tx.com/</a>, and follow us on <a href="https://x.com/dyne_tx">X</a>, <a href="https://www.linkedin.com/company/dynetx/">LinkedIn</a> and <a href="https://www.facebook.com/DyneTherapeutic/">Facebook</a>.</p></div><p><strong>Role Summary:</strong></p> <p><span data-contrast="none">The Senior Manager, Clinical Programming is responsible</span><span data-contrast="auto"> </span><span data-contrast="none">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.</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":200,"335559740":276}"> </span></p> <p><span data-contrast="none">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. </span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":200,"335559740":276}"> </span></p> <p><span data-contrast="none">This role is based in Waltham, MA.</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":200,"335559740":276}"> </span></p> <p><strong><span data-contrast="none">Primary Responsibilities Include:</span></strong><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":200,"335559740":276}"> </span></p> <ul> <li><span data-contrast="auto">Oversee assigned day-to-day clinical programming activities, timelines, and deliverables for assigned projects</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Collaborate with clinical operations, biostatistics, and data management teams to develop project timelines and ensure alignment of programming deliverables with clinical study objectives</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Monitor project progress, identify potential issues, and implement solutions to mitigate risks</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Provide technical and business expertise in support of data deliverables</span><span data-ccp-props="{"134245417":false,"201341983":2,"335557856":16777215,"335559739":0,"335559740":300,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Ensure compliance with internal polices, SOPs, and Work Instructions as well as external regulatory requirements related to clinical data management and programming </span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Conduct quality checks and audits of programming deliverables to guarantee accuracy and integrity</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Identify opportunities for process improvements within clinical programming and data management practices and implement changes to enhance efficiency and quality</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Effectively interact with vendors</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Anticipate internal business challenges and successfully drive towards the best solution for the organization</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Participate in effective planning and execution of programming tasks </span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Ensure timeliness and quality of data report deliverables in collaboration with Clinical Data Management team members and cross-functional colleagues</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Enable consistent programming approaches, standards adoption, and best practices</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Work closely with stakeholders to support data analysis and reporting needs</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Participate in initiatives around process development, standardization, and technology</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Contributes to selection and use of complex programming solutions to enhance clinical data collection and reporting</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Provide oversight of programming tasks performed by third-party vendors and data management Contract Research Organizations (CROs) as assigned</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Stay current with emerging technologies and methodologies relevant to the role</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> </ul> <p><strong><span data-contrast="none">Education and Skills Requirements:</span></strong><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":200,"335559740":276}"> </span></p> <ul> <li><span data-contrast="auto">6+ years of experience clinical programming with a focus on clinical data management and analysis within the pharma/biotech industry</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335557856":16777215,"335559739":200,"335559740":240}"> </span></li> <li><span data-contrast="auto">Bachelor’s degree in life science or related discipline required, advanced degree preferred</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Has in-depth knowledge of clinical database design, data standards, and data output programming expertise</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Demonstrates ability to anticipate internal business challenges and successfully drives towards the best solution for the organization</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Ability to perform short term tactical planning, typically for a 6-month horizon</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Able to work in a highly matrixed, fast-paced environment with changing priorities and deadlines</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Highly organized and detail oriented</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Demonstrates strong collaboration skills with external service providers and cross-functional teams</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Experience with project management and meeting facilitation skills</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Able to manage time effectively and prioritize</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">GCP knowledge</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Demonstrated experience in writing professional correspondence and clinical study documentation</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Data modeling, listing, and visualization development experience with elluminate</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">EDC experience in various EDC systems, e.g., Medidata Rave</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">SAS programming experience a plus</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Strong working knowledge of CDISC Standards (CDASH, SDTM, ADaM)</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Strong understanding of clinical trial data</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Strong communication skills both verbal and written, with the ability to collaborate effectively with diverse teams</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> <li><span data-contrast="auto">Excellent problem-solving abilities and attention to detail</span><span data-ccp-props="{"134245417":false,"201341983":0,"335559739":0,"335559740":240,"469777462":[220,720],"469777927":[0,0],"469777928":[1,1]}"> </span></li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="title">MA Pay Range</div><div class="pay-range"><span>$143,000</span><span class="divider">—</span><span>$175,000 USD</span></div></div></div><div class="content-conclusion"><p> </p> <p>The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.</p> <p>The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.</p> <p class="Body"><em><span style="font-family: 'Arial',sans-serif; color: #626262;">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.</span></em></p></div>