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.