Senior Manager, Clinical Programming

Role Summary

The Senior Manager, Clinical Programming is responsible for overseeing programming activities for clinical trial data and ensuring high-quality data management and reporting to regulatory standards. The role collaborates with clinical operations, biostatistics, and data management to enable successful trials, build analytical databases, support regulatory submissions, and contribute to clinical study reports. It leads programming projects across EDC, external data handling, and data visualization from study start-up to close-out, in accordance with SOPs and ICH-GCP. This position is based in Waltham, MA.

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 policies, 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

Qualifications

• 6+ years of experience clinical programming with a focus on clinical data management and analysis within the pharma/biotech industry
• 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

Education

• Bachelor’s degree in life science or related discipline required; advanced degree preferred

Skills

• GCP knowledge
• 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