Monte Rosa Therapeutics
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Director, Clinical Data Management
role at
Monte Rosa Therapeutics
Overview 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.
Base pay range $145,000.00/yr - $180,000.00/yr
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.
Responsibilities
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
Qualifications
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 (e.g 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
Application details Interested Candidates may forward a CV and Cover Letter in a single PDF via our on-line portal 2 weeks ago
About Monte Rosa Therapeutics Monte Rosa Therapeutics is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases in the areas of oncology, autoimmune and inflammatory diseases, and more. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design MGDs with unprecedented selectivity. Monte Rosa has developed the industry’s leading pipeline of MGDs, which spans autoimmune and inflammatory diseases, oncology, and beyond. Monte Rosa has a global license agreement with Novartis to advance VAV1-directed molecular glue degraders and a strategic collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug. For more information, visit www.monterosatx.com.
Seniority level
Director
Employment type
Full-time
Job function
Research
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Director, Clinical Data Management
role at
Monte Rosa Therapeutics
Overview 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.
Base pay range $145,000.00/yr - $180,000.00/yr
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.
Responsibilities
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
Qualifications
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 (e.g 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
Application details Interested Candidates may forward a CV and Cover Letter in a single PDF via our on-line portal 2 weeks ago
About Monte Rosa Therapeutics Monte Rosa Therapeutics is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases in the areas of oncology, autoimmune and inflammatory diseases, and more. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design MGDs with unprecedented selectivity. Monte Rosa has developed the industry’s leading pipeline of MGDs, which spans autoimmune and inflammatory diseases, oncology, and beyond. Monte Rosa has a global license agreement with Novartis to advance VAV1-directed molecular glue degraders and a strategic collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug. For more information, visit www.monterosatx.com.
Seniority level
Director
Employment type
Full-time
Job function
Research
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr