Sr. Director of Clinical Data Management
Sr. Director Clinical Data Management San Diego, CA - Hybrid 198,000-286,000 A leading biotech company, based in San Diego, is advancing its first two programs into the clinic this year. Their advanced drug discovery platform uses cutting-edge technology to design highly targeted cancer therapies. This innovative approach aims to create precise treatments with improved efficacy and reduced side effects, driving their mission to revolutionize cancer care .Backed by over $200 million in funding from top-tier investors, the company is well-positioned for rapid growth. The leadership team includes an award-winning CEO recognized for entrepreneurial excellence and a CMO with a distinguished track record in precision medicine and immunotherapy. Joining this company means contributing to innovative cancer treatments within a dynamic, well-funded environment alongside passionate experts committed to transforming oncology. The Senior Director of Clinical Data Management Responsibilities will include: Leading clinical data management oversight of clinical trials, including project management, CRO management, coordination of internal reviews, and approval of routine data management deliverables. Setting up data management vendors as required, including the review of RFPs, evaluating, and negotiating data management budgets and contracts. Leading the development and review of all Clinical Data Management-related documents, including Data Management Plans, CRF design and CRF Completion Guidelines, edit check specifications, data transfer plans, etc. Liaising with study management CRO and internal cross-functional teams to ensure adequate site training, timely initiation, and overall data integrity. Providing direction and guidance to team members, including consultants and vendors, as well as other cross-functional groups to achieve study goals and milestones. Overseeing database design and post-production updates, ensuring that CROs, vendors, and internal staff meet the highest quality standards per the latest industry standards and regulatory requirements. Being responsible for sponsor user acceptance testing, including documenting findings and resolving issues with CRO. Overseeing data management activities, including reconciliation between external data and EDC data, data flow metrics, database migration, medical coding, and driving data snapshot/closeout activities. Proactively identifying risks and executing risk mitigation strategies; maintaining timely communication with both upper management and cross-functional teams. Supervising CRO/Vendor activities to ensure GCP compliance, quality expectations are met, and timelines are adhered to. Contributing to program deliverable timeline creation and project re-forecasting. Supporting data management activities for regulatory submissions. Leading the development of CDM-related Standard Operating Procedures (SOPs) and Work Instructions. Performing additional duties as assigned. Qualifications Bachelor's degree mandatory, with a minimum of 6years hands-on data management experience in the CRO, biotech, or pharmaceutical sector. Oncology experience required. Strong vendor management skills
US$198000 - US$286000 per year
San Diego
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Sr. Clinical Data Manager
Sr. Clinical Data Manager San Diego, CA - Hybrid $220,000-$286,000 A leading biotech company, based in San Diego, is advancing its first two programs into the clinic this year. Their advanced drug discovery platform uses cutting-edge technology to design highly targeted cancer therapies. This innovative approach aims to create precise treatments with improved efficacy and reduced side effects, driving their mission to revolutionize cancer care .Backed by over $200 million in funding from top-tier investors, the company is well-positioned for rapid growth. The leadership team includes an award-winning CEO recognized for entrepreneurial excellence and a CMO with a distinguished track record in precision medicine and immunotherapy. Joining this company means contributing to innovative cancer treatments within a dynamic, well-funded environment alongside passionate experts committed to transforming oncology. The Senior Director of Clinical Data Management Responsibilities will include: Leading clinical data management oversight of clinical trials, including project management, CRO management, coordination of internal reviews, and approval of routine data management deliverables. Setting up data management vendors as required, including the review of RFPs, evaluating, and negotiating data management budgets and contracts. Leading the development and review of all Clinical Data Management-related documents, including Data Management Plans, CRF design and CRF Completion Guidelines, edit check specifications, data transfer plans, etc. Liaising with study management CRO and internal cross-functional teams to ensure adequate site training, timely initiation, and overall data integrity. Providing direction and guidance to team members, including consultants and vendors, as well as other cross-functional groups to achieve study goals and milestones. Overseeing database design and post-production updates, ensuring that CROs, vendors, and internal staff meet the highest quality standards per the latest industry standards and regulatory requirements. Being responsible for sponsor user acceptance testing, including documenting findings and resolving issues with CRO. Overseeing data management activities, including reconciliation between external data and EDC data, data flow metrics, database migration, medical coding, and driving data snapshot/closeout activities. Proactively identifying risks and executing risk mitigation strategies; maintaining timely communication with both upper management and cross-functional teams. Supervising CRO/Vendor activities to ensure GCP compliance, quality expectations are met, and timelines are adhered to. Contributing to program deliverable timeline creation and project re-forecasting. Supporting data management activities for regulatory submissions. Leading the development of CDM-related Standard Operating Procedures (SOPs) and Work Instructions. Performing additional duties as assigned. Qualifications Bachelor's degree mandatory, with a minimum of 6years hands-on data management experience in the CRO, biotech, or pharmaceutical sector. Oncology experience required. Strong vendor management skills
US$220000 - US$286000 per year
San Diego
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Senior Biostatistician
Senior Biostatistician We are seeking an experienced and highly skilled Senior Biostatistician to join our client's growing Biostatistics team. In this role, you will play a key part in the design, analysis, and interpretation of clinical trial data across a variety of therapeutic areas. You will work closely with cross-functional teams to ensure high-quality statistical methods are applied to clinical research, contributing to the advancement of innovative medical treatments. Key Responsibilities: Lead the statistical design and analysis of clinical trials, ensuring compliance with regulatory requirements and industry standards. Collaborate with clinical teams to interpret data, provide insights, and support decision-making throughout the trial lifecycle. Develop statistical analysis plans (SAPs) and perform complex statistical analyses using a range of methodologies. Communicate statistical results clearly and effectively to both technical and non-technical stakeholders. Mentor junior statisticians and provide guidance on statistical best practices. Qualifications: PhD in Biostatistics, Statistics, or a related field. Extensive experience in statistical analysis, with a strong background in clinical trials and regulatory submissions. Proficiency in statistical software such as SAS, R, or other relevant tools. Strong communication and collaboration skills, with the ability to work across teams and present findings to diverse audiences.
US$120000 - US$140000 per year
United States of America
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