Manager, Clinical Systems & Metrics

The Manager, CTMS & eTMF Processes is responsible for supporting and optimizing business processes related to the Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF). This role focuses on ensuring efficient collaboration between internal users and external business partners while maintaining compliance with standard operating procedures and inspection readiness requirements. The Manager will serve as a key resource for process-related inquiries, training, and documentation to enhance the overall usability and effectiveness of the systems. This position will report into the Associate Director, CTMS & eTMF Process Owner.

This position is open to remote working and will be primarily located at the Cambridge, MA headquarters.

Key Responsibilities

Process Optimization and Compliance

• Collaborate with the Associate Director, Process Specialist, to assess, document, and continuously improve CTMS and eTMF processes, ensuring alignment with industry best practices and regulatory requirements.
• Conduct process mapping exercises to identify inefficiencies, redundancies, and gaps in current workflows and propose enhancements.
• Lead process improvement initiatives by analyzing user feedback, system performance metrics, and audit findings to develop and implement corrective actions.
• Partner with Clinical Operations, Quality, and IT teams to drive enhancements in system functionality, ensuring alignment between technology and business needs.
• Develop and implement standardized workflows that enhance the consistency and accuracy of data entry, document management, and reporting within CTMS and eTMF.
• Evaluate and recommend automation solutions or system configurations that improve process efficiency and reduce manual workload.
• Support change management efforts by ensuring stakeholders are informed and engaged in process changes through communication, training, and documentation.

User Support & Training

• Serve as a primary point of contact for internal users and external business partners, addressing process-related questions and system issues.
• Develop and maintain user guides, process documentation, and training materials to support system adoption and compliance.
• Conduct training sessions to ensure users understand system functionality and best practices for data entry and document management.

Metrics & Reporting

• Develop and distribute standardized reports on CTMS and eTMF performance, focusing on data quality, completeness, timeliness, and adherence to regulatory and internal expectations.
• Establish key performance indicators (KPIs) for CTMS and eTMF processes, such as milestone completion rates, document processing times, query resolution efficiency, and inspection readiness scores.
• Conduct regular data audits to identify discrepancies, missing data, or compliance gaps, and collaborate with relevant teams to drive corrective actions.
• Utilize dashboards and visualization tools to provide stakeholders with real-time insights into system performance, study progress, and document compliance.
• Monitor trends in user activity and system usage to identify training needs and process bottlenecks, making data-driven recommendations for improvement.
• Partner with IT and business intelligence teams to enhance reporting capabilities and integrate data from multiple sources for comprehensive process analysis.
• Generate inspection readiness reports, tracking document status, audit trails, and compliance with regulatory requirements to proactively address potential risks.
• Develop and refine data governance frameworks to ensure consistency, accuracy, and security of clinical trial data across CTMS and eTMF platforms.

Qualifications

• Bachelor's degree in Life Sciences, Clinical Research, Business, or a related field.
• Minimum of 5 years of experience in clinical operations, clinical systems management, or a related function within the pharmaceutical, biotechnology, or CRO industry.
• Experience with CTMS and eTMF systems and an understanding of clinical trial processes.
• Experience with Veeva Vault and/or Medidata CTMS preferred.
• Knowledge of GCP, ICH guidelines, and regulatory requirements related to clinical documentation.

Skills & Competencies

• Strong understanding of clinical trial workflows and system integrations.
• Excellent problem-solving and analytical skills to identify process inefficiencies and implement improvements.
• Ability to develop and deliver effective training and user documentation.
• Strong communication and interpersonal skills to work effectively across teams and external partners.
• Proficiency in generating and analyzing system metrics reports.

About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.