Sr. Manager, Translational Operations

Job Title: Sr. Mgr, Translational Operations

Introduction to role

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!

Accountabilities

• 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

Essential Skills/Experience

• 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

Desirable Skills/Experience
• 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.

Ready to take on this exciting challenge? Apply now!

The annual base salary for this position ranges from $115,000 to $173,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.