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Project and Data Manager 1, Integrated Bioanalysis

Lieu South San Francisco, Californie, États-Unis Job ID R-141231 Date de publication 06/18/2022

Project and Data Manager 1, Integrated Bioanalysis

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

We are seeking a skilled and motivated scientist-project manager to join our group within Integrated Bioanalysis.  We have a diverse team of scientists working across many technologies to provide high quality, decision-driving data.  This position will focus on data and project management associated with delivering bioanalysis on clinical trials.  Results from bioanalytical assays are widely used to monitor performance of immune modulating therapeutics and provide valuable data for dose escalation, go/ no-go decision, and dose selection decisions to ensure our medicines get to the right patient at the right time in the right dose.  You will work with experienced scientist specialists and the clinical trials teams to implement validated bioanalytical assays at third-party laboratory vendors, monitor testing throughout the life of studies, assist with data transfers design and execution, and deliver cleaned data sets for interpretive analysis that are suitable for inclusion in clinical study reports.

What you’ll do:

  • Manage contracting with third-party lab service providers for complex assay development and validation, and assist our clinical trials department with appropriate contracting of assay testing on clinical trials

  • Coordinate with clinical trial teams and third-party lab service providers to review, edit, and finalize documents for delivery of the required lab services and ensure study timelines are met

  • Work with data programmers and bioinformaticians to drive delivery of data transfer specifications and the associated data

  • Address issues that arise in data transfers and drive cleaning and reconciliation of the data for data finalization.

  • Additional opportunities to contribute to scientific interpretation of data commensurate with experience and ability

Required for the role:

  • BA/BS or higher degree with a background in medical science.

  • Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and AstraZeneca expectations

  • Familiar with clinical trials design with an ability to read a clinical study protocol and understand the study design and data outputs (i.e., dosing regimen, cohort requirements, secondary and exploratory data outputs, schedule of assessments)                      

  • Familiar with data transfer agreement/specifications

  • Basic understanding of reconciliation/cleaning of clinical data and generating queries for resolution

  • Ability to support project resourcing and project timeline planning and adherence to timelines

  • Good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detail

  • Strong interpersonal communication skills and the ability to work and collaborate effectively on cross-functional teams

  • Ability to work productively in both a team environment and independently as needed

  • Proficiency with Excel and/or Spotfire or Jump or other interactive computer programs

Desirable for the role:

  • Familiarity with flow cytometry datasets a plus but not required

  • Familiarity with contract research organizations and central laboratories preferred

  • Informatics and programming expertise is not required but is highly desired and experience in this regard may offset inexperience in other requirements

  • Familiarity with other immunoassays helpful but not required

  • Knowledge of GCP regulations helpful

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

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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 authorisation and employment eligibility verification requirements.

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