Director, Clinical Data Management

Monte Rosa Therapeutics is seeking an experienced and strategic Director of Clinical Data Management to lead and grow our data management function. This role is ideal for a hands-on leader who thrives in a fast-paced biotech environment and is passionate about building scalable data systems that support high-quality clinical trials. You will be responsible for overseeing all aspects of clinical data management across our pipeline, ensuring data integrity, compliance, and readiness for regulatory submission.

• As the Director of Clinical Data Management reporting to the SVP, Clinical Development Operations, you will be responsible for all clinical data management activities for Monte Rosa clinical studies
• Develop and implement the clinical data management strategy aligned with company goals and regulatory requirements.
• Establish and maintain relationships with external vendors, ensuring effective communication and collaboration to meet project timelines and deliverables
• Lead the planning, execution, and delivery of data management activities across all phases of clinical trials.
• Lead and manage CRO/fully outsourced trials to enable effective data review as well as operational metrics
• Oversee database design, CRF development, data cleaning, coding, and database lock processes.
• Ensure timely and accurate data collection, validation, and reporting.
• Establish and maintain SOPs, data standards, and quality metrics.
• Review of plans and provision of CDM expertise during protocol design, study start up and conduct phases of studies
• Collaborate on Data Transfer Agreements and oversee vendor data tasks
• Ensure compliance with GCP, ICH guidelines, and relevant regulatory requirements.
• Partner with Clinical Operations, Biostatistics, Medical, and Regulatory teams to support study design, data strategy, and submission readiness.
• Serve as the primary data management contact for internal stakeholders and external partners.
• Evaluate and implement data management systems and tools (ie. EDC, ePRO, eCOA).
• Drive innovation in data collection, integration, and visualization in support clinical insights.
• Bachelor's or Master’s degree in Life Sciences, Health Informatics or related field.
• 10+ years of experience in clinical data management, with at least 3 years in a leadership role.
• Proven experience managing data for phase I-III trials, preferably in oncology and or autoimmune and inflammatory diseases.
• Strong knowledge of industry standards, regulatory requirements, and best practices related to clinical data management
• Understanding of clinical trial methodologies, data collection processes, and data analysis techniques
• Demonstrated ability to lead and motivate a team, providing guidance and support
• Strong collaboration and interpersonal skills, with the ability to communicate effectively with cross-functional teams, external vendors, and senior management
• Problem-solving and decision-making abilities, with a track record of successfully resolving complex issues
• Hands-on deep experience working with EDC systems (e.g. Rave, Medrio, Inform)
• Proficiency in Data Management Review systems and tools (i.e JReview, Spotfire, etc.)
• Experience in a small biotech or startup environment is highly desirable.
• Comfortable in a fast paced, results-driven, highly accountable environment with large potential impact.
• 20% travel required.