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 Bachelors 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 $115000 to $173000. However base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and 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.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.