Operations Specialist

Astrazeneca Waltham , MA 02154

Posted 2 months ago

Operations Specialist

Waltham, MA

AstraZeneca is a global, science-driven biopharmaceutical company. We are dedicated to discovering, developing, and delivering innovative, meaningful medicines and healthcare solutions that enrich the lives of patients. In AstraZeneca Oncology, our goal is to be at the forefront of developing the next generation of cancer therapies.

As the Operations Specialist, you will lead operational delivery of the biomarker plan for individual clinical studies. This will be based on strategy led by the translational medicine leader and agreed by product teams working closely with the clinical team and other supporting functions.

You will also lead laboratory sample management activities by implementing system improvements and supervising sample receiving and tracking activities.

Responsibilities

  • Lead the delivery of the biomarker plan for individual clinical studies, ensuring that is based on translational strategy led by translational medicine leader and agreed by product teams working closely with the clinical team and other supporting functions.

  • Engage and leverage Translational Medicine expertise where novel technologies or vendors are being considered

  • Work effectively with procurement to contract the biomarker operations to deliver fit-for purpose laboratory testing from sample receipt to delivery of results, compliant with clinical sample testing guidelines where necessary.

  • Ensure biomarker plan commits CROs/laboratories to deliver timely, fit for purpose testing with sufficient clarity on input for the clinical team to develop site requirements and contracts for sample logistics.

  • Ensure regulatory function supplied with relevant testing data to support risk determination assessment

  • Lead the creation and maintenance of study documents such as communication, quality management and issue escalation plans

  • Ensure the frequency and content of data outputs for patient selection and/or exploratory measures are delivered as agreed with vendor and clinical team

  • Ensure relevant sample meta-data effectively captured in clinical database

  • Review and approve sample instructions for clinical sites

  • Monitor biomarker data quality and timeliness via agreed QC plan, provide scientific troubleshooting when necessary

  • Build and maintain a knowledge of current and emerging biomarker assay technologies in area of expertise.

  • Be accountable for the time, cost and quality of agreed deliverables.

  • Provide dedicated Translational Medicine Alliance Management support for assigned vendor(s) as needed, working with Scientific Program Manager for matters requiring escalation

  • Identify risks and escalate as needed

  • Supervise shipping, receiving, accessioning of samples and maintenance of storage systems and information within AZ TM labs.

  • Timely identification and resolution of discrepancies in sample information between AZ, central lab, biobank, and clinical sites.

  • Collaborate with laboratory personnel to develop improvements in implementation of laboratory sample management.

  • Collaborate with project leads to assess current and future biospecimen needs and provide sample logistics support, as needed.

  • Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and address instances of non-compliance.

Essential Requirements

  • Bachelor's degree required with 6 month to 3 years of relevant experience in the biopharmaceutical industry

  • Ability to communicate with stakeholders for study updates, testing progress through oral presentations and progress reports

Skills & Capabilities

  • Good interpersonal skills and ability to act as an ambassador for TM/AZ internally and externally

  • Ability to interact successfully with multiple customers across functional boundaries

  • Ability to work independently, designing, executing and interpreting tasks

  • Can identify and address critical issues in the context of strategic direction

  • A confident team player who is assertive but willing to listen and learn from the views of others

  • Ability to influence within own discipline and apply constructive challenge

  • Excellent organizational skills, with the proven ability to deliver high quality work under pressure and against tight timelines

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

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Operations Specialist

Astrazeneca