Sr. Manager, Translational Operations

Sr. Mgr, Translational Operations

Are you ready to make a significant impact in the world of biopharmaceuticals? As a key member of the Biosamples team, you will support clinical sample life-cycle management across multiple global clinical trials. Your expertise will optimize the logistics and use of our clinical trial samples, ensuring our scientists have timely access to all available samples to answer new research questions. This role is crucial in delivering on our promise to rare disease patients and advancing our science. This position can be based in Boston, MA or New Haven, CT!

Management of bioanalytical, biomarker, and other translational collections from multiple global clinical trials

Maintenance of sample chain-of-custody in a GxP-compliant setting

Oversight of all operational activities required to ensure high-quality sample processing, shipping, receiving, and storage of biological research samples

Support collaborations 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

Tracking lessons learned and applying them across trials for consistency and continuous improvement activities

Contributing to clinical lab training materials & review of laboratory manuals

Supporting virtual or onsite training meetings

Supporting communications and building relationships with key stakeholders including CROs, vendors, and external collaborators

Potential direct contact with local country teams, CRA, or clinical sites

Ensuring completion, deployment, and accuracy of the Sample Lifecycle Plan, or equivalent

Utilizing tracking systems to report progress, address issues, and bring them to resolution

Ensuring all samples collected as part of protocol or outside of protocol are dispositioned

Representing translation operations at meetings to ensure deliverables related to clinical trial samples are met

Liaising with Data Management, Clinical Operations, and Translational Sciences colleagues to resolve translational sample-related data queries and sample-related issues at sites or analysis labs

Providing input into clinical trial protocols / synopses and informed consent forms to ensure logistical feasibility of clinical sample strategy as well as alignment with all Clinical Sample Plans, ICH / GCP, and local regulations

Maintaining quality documentation and assigned Trial Master Files for assigned studies

Assisting with tracking appropriate metrics for the Translational Sciences and Biosamples teams

Minimum of 6+ years of biopharmaceutical R&D experience in drug development and participation in projects involving vendors and cross-functional teams, or equivalent experience

A 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 to meet deadlines with a can-do attitude

Excellent communication and organizational skills, along with problem-solving and conflict resolution

Proficiency in MS Office (i.e. Word, Excel, PowerPoint), Adobe Acrobat, and SmartSheet

Experience in implementing and using sample management / tracking systems, e.g., Laboratory Information Management System (LIMS)

Demonstrated experience in inventory management and forecasting

Capability to support a strategic vision and deliver operational excellence

Experience with rare disease clinical trials

Project management and / or Lean Six-sigma training

At AstraZeneca, we are dedicated to making a profound impact on society by applying our expertise in innovative ways. Our collaborative environment encourages continuous learning and improvement. We value diverse perspectives and empower our team members to make bold decisions that drive scientific advancements. Join us in our mission to deliver life-changing medicines to patients worldwide.