Planet Pharma
Mgr Clinical Biomarkers & Diagnostics
Planet Pharma - California, Missouri, United States, 65018
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Overview
Clinical Biomarkers & Diagnostics Manager
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Clinical Biomarkers & Diagnostics Manager
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Planet Pharma . Job Overview
The Clinical Biomarker and Diagnostics (CBD) Operations Lead is responsible for planning and coordinating project management and operational activities to implement biomarker and diagnostics strategies in therapeutic areas such as Rare Disease, Inflammation, and Cardio Metabolic Medicine. This role ensures project continuity, coordinates assay development, and acts as the primary contact for CBD operations related to biomarker and diagnostic activities, including biosample collection, delivery, and analysis. Additionally, the role manages sub-team meetings, dashboards, and tracking of biomarker deliverables. Key Responsibilities
Implement and execute clinical biomarker and diagnostic plans across early and late-stage clinical development programs. Develop and oversee biosample collection, processing, and storage strategies, ensuring logistical feasibility and cost efficiency. Manage project budgets, timelines, and forecasting related to biomarker analysis and sample management. Coordinate biosample collection protocols, including material definition, instructions, lab manual development, and database setup. Ensure data quality and consistency with collection and assay plans. Serve as the main contact for operational questions regarding biosample management and coordinate with internal and external partners. Create sample reconciliation plans and manage data collection and reporting activities. Review study protocols and consent forms to ensure compatibility with biomarker plans. Train site staff on sample collection during initiation visits. Oversee the implementation of clinical trial assays at reference labs and vendors, ensuring timely delivery of results. Manage contracts, budgets, and timelines for biomarker activities within studies. Qualifications
Life Sciences degree (MSc or higher preferred). Project management certification is desirable. At least 4 years of experience in a clinical research, laboratory, or biotech environment. Extensive experience (2+ years) in biomarker operations and biosample management. Strong project management skills and experience with project management tools. Excellent problem-solving, organizational, and communication skills. Minimum Education & Experience
Doctorate, or Master’s with 3+ years, or Bachelor’s with 5+ years, or Associate’s with 10+ years, or High School diploma with 12+ years of experience. Leadership experience in managing teams or projects is required. Additional Information
This is a full-time position. The role is not applicable to any specific seniority level. The employer is an equal opportunity organization that values diversity and inclusion.
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Join to apply for the
Clinical Biomarkers & Diagnostics Manager
role at
Planet Pharma . Job Overview
The Clinical Biomarker and Diagnostics (CBD) Operations Lead is responsible for planning and coordinating project management and operational activities to implement biomarker and diagnostics strategies in therapeutic areas such as Rare Disease, Inflammation, and Cardio Metabolic Medicine. This role ensures project continuity, coordinates assay development, and acts as the primary contact for CBD operations related to biomarker and diagnostic activities, including biosample collection, delivery, and analysis. Additionally, the role manages sub-team meetings, dashboards, and tracking of biomarker deliverables. Key Responsibilities
Implement and execute clinical biomarker and diagnostic plans across early and late-stage clinical development programs. Develop and oversee biosample collection, processing, and storage strategies, ensuring logistical feasibility and cost efficiency. Manage project budgets, timelines, and forecasting related to biomarker analysis and sample management. Coordinate biosample collection protocols, including material definition, instructions, lab manual development, and database setup. Ensure data quality and consistency with collection and assay plans. Serve as the main contact for operational questions regarding biosample management and coordinate with internal and external partners. Create sample reconciliation plans and manage data collection and reporting activities. Review study protocols and consent forms to ensure compatibility with biomarker plans. Train site staff on sample collection during initiation visits. Oversee the implementation of clinical trial assays at reference labs and vendors, ensuring timely delivery of results. Manage contracts, budgets, and timelines for biomarker activities within studies. Qualifications
Life Sciences degree (MSc or higher preferred). Project management certification is desirable. At least 4 years of experience in a clinical research, laboratory, or biotech environment. Extensive experience (2+ years) in biomarker operations and biosample management. Strong project management skills and experience with project management tools. Excellent problem-solving, organizational, and communication skills. Minimum Education & Experience
Doctorate, or Master’s with 3+ years, or Bachelor’s with 5+ years, or Associate’s with 10+ years, or High School diploma with 12+ years of experience. Leadership experience in managing teams or projects is required. Additional Information
This is a full-time position. The role is not applicable to any specific seniority level. The employer is an equal opportunity organization that values diversity and inclusion.
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