Local Study Manager
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Local Study Manager, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
As a Local Study Manager (LSM) you will lead Local Study Team(s) (LSTs) in North America to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), LSM is expected to perform site monitoring if needed. As part of the flexible capacity model it is expected that the LSM manages both roles. LSM is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
- Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA.
- Lead Local Study Team(s) consisting of monitors and study administrator(s).
- Lead and optimise the performance of the local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters
- Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from respective Study Team.
- Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on study related matters.
- Perform any required co-monitoring & QC visits with study monitor(s)
- Proactively identify and facilitate resolution of complex study problems and issues.
- Ensure timely preparation of country SMA, fSMA and Master CSA.
- Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority.
- Assist Line Managers (SMM Director/CRM) in efficient functioning of the department at country level.
- Prepare and maintain study budget at country level in ACCORD.
- Liaise with Local Compliance Officer regarding payments to Investigators to ensure these are in accordance with local requirements.
- BS or BA degree and / or equivalent, preferred in biological science or healthcare-related field.
- 3+ years experience in Clinical Operations or other related fields (Medical Affairs-led studies or Academic-led studies)
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.
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.