Alexion Pharmaceuticals, Inc.
Sr. Manager, Translational Operations
Alexion Pharmaceuticals, Inc., Boston, Massachusetts, us, 02298
Overview
Job Title: Sr. Mgr, Translational Operations. Introduction to role: You will support clinical sample life-cycle management across multiple global clinical trials, optimizing the logistics and use of our clinical trial samples to ensure timely access for scientists. This role is crucial in delivering on our promise to rare disease patients and advancing our science. Location options: Boston, MA or New Haven, CT. Responsibilities
Manage bioanalytical, biomarker, and other translational collections from multiple global clinical trials Maintain sample chain-of-custody in a GxP-compliant setting Oversee operational activities for high-quality sample processing, shipping, receiving, and storage Collaborate with Clinical Operations, Data Management, Biostatistics, and vendors for data transfer, reconciliation, and analysis needs Input to kit design, sample processing, collection storage, and shipping Track lessons learned and apply them across trials for consistency and continuous improvement Contribute to clinical lab training materials and review laboratory manuals Support virtual or onsite training meetings Support communications and build relationships with key stakeholders including CROs, vendors, and external collaborators Direct contact with local country teams, CRAs, or clinical sites as needed Ensure completion, deployment, and accuracy of the Sample Lifecycle Plan or equivalent Utilize tracking systems to report progress, address issues, and drive resolution Ensure samples collected as part of protocol or outside protocol are dispositioned Represent translation operations at meetings to ensure deliverables related to clinical trial samples are met Coordinate with Data Management, Clinical Operations, and Translational Sciences to resolve sample-related data queries and issues Provide input into clinical trial protocols/synopses and informed consent forms to ensure logistical feasibility and alignment with Clinical Sample Plans, ICH/GCP, and local regulations Maintain quality documentation and assigned Trial Master Files for assigned studies Assist with tracking appropriate metrics for Translational Sciences and Biosamples teams Essential Skills/Experience
Minimum of 6+ years of biopharmaceutical R&D experience in drug development with vendor and cross-functional team collaboration, or equivalent Bachelor's Degree in Life Sciences (e.g., BSc, MSc), Regulatory compliance or related field Direct experience with clinical sample management and/or clinical trial management Knowledge of GCP, GDP, GLP requirements Ability to work effectively in a fast-paced environment and meet deadlines with a can-do attitude Excellent communication and organizational skills, plus problem-solving and conflict resolution abilities Proficiency in MS Office (Word, Excel, PowerPoint), Adobe Acrobat, and SmartSheet Desirable Skills/Experience
Experience implementing and using sample management/tracking systems (e.g., LIMS) Demonstrated experience in inventory management and forecasting Ability to support a strategic vision and deliver operational excellence Experience with rare disease clinical trials Project management and/or Lean Six Sigma training Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. If you have a disability or special need that requires accommodation, please notify the application team. We are committed to equal opportunity and diversity in all our practices.
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Job Title: Sr. Mgr, Translational Operations. Introduction to role: You will support clinical sample life-cycle management across multiple global clinical trials, optimizing the logistics and use of our clinical trial samples to ensure timely access for scientists. This role is crucial in delivering on our promise to rare disease patients and advancing our science. Location options: Boston, MA or New Haven, CT. Responsibilities
Manage bioanalytical, biomarker, and other translational collections from multiple global clinical trials Maintain sample chain-of-custody in a GxP-compliant setting Oversee operational activities for high-quality sample processing, shipping, receiving, and storage Collaborate with Clinical Operations, Data Management, Biostatistics, and vendors for data transfer, reconciliation, and analysis needs Input to kit design, sample processing, collection storage, and shipping Track lessons learned and apply them across trials for consistency and continuous improvement Contribute to clinical lab training materials and review laboratory manuals Support virtual or onsite training meetings Support communications and build relationships with key stakeholders including CROs, vendors, and external collaborators Direct contact with local country teams, CRAs, or clinical sites as needed Ensure completion, deployment, and accuracy of the Sample Lifecycle Plan or equivalent Utilize tracking systems to report progress, address issues, and drive resolution Ensure samples collected as part of protocol or outside protocol are dispositioned Represent translation operations at meetings to ensure deliverables related to clinical trial samples are met Coordinate with Data Management, Clinical Operations, and Translational Sciences to resolve sample-related data queries and issues Provide input into clinical trial protocols/synopses and informed consent forms to ensure logistical feasibility and alignment with Clinical Sample Plans, ICH/GCP, and local regulations Maintain quality documentation and assigned Trial Master Files for assigned studies Assist with tracking appropriate metrics for Translational Sciences and Biosamples teams Essential Skills/Experience
Minimum of 6+ years of biopharmaceutical R&D experience in drug development with vendor and cross-functional team collaboration, or equivalent Bachelor's Degree in Life Sciences (e.g., BSc, MSc), Regulatory compliance or related field Direct experience with clinical sample management and/or clinical trial management Knowledge of GCP, GDP, GLP requirements Ability to work effectively in a fast-paced environment and meet deadlines with a can-do attitude Excellent communication and organizational skills, plus problem-solving and conflict resolution abilities Proficiency in MS Office (Word, Excel, PowerPoint), Adobe Acrobat, and SmartSheet Desirable Skills/Experience
Experience implementing and using sample management/tracking systems (e.g., LIMS) Demonstrated experience in inventory management and forecasting Ability to support a strategic vision and deliver operational excellence Experience with rare disease clinical trials Project management and/or Lean Six Sigma training Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. If you have a disability or special need that requires accommodation, please notify the application team. We are committed to equal opportunity and diversity in all our practices.
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