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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.The Local Study Manager (LSM) will lead Local Study Team(s) (LSTs) at country level 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), Local Study Manager (LSM) is expected to perform site monitoring if needed. As part of the flexible capacity model it is expected that LSM’s manages both roles. LSM is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.Major responsibilities
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.
Ensure completeness of the Study Master File and ensure essential documents are sent to SMO/Hub location/site.
Plan and lead activities associated with audits and regulatory inspections in liaison with Clinical Process Manager and QA.
Provide input to process development and improvement.
Provide regular information to Line Managers (SMM Director/CRM) at country level on study/ies and planned study milestones/key issues.
Update Line Managers (SMM Director/CRM) about the performance of the monitors/CRAs.
Ensure that study activities at country level comply with local policies & code of conduct.
For CRA work, see Monitor Job Description
Additional Responsibilities
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.
Timely preparation and support to process of registration of applicable clinical studies in country-specific or regional websites.
Ensure that clinical and operational feasibility assessment of Study Design Concept and Clinical Study Protocol is performed to highest quality.
Keep track on research intelligence in local markets.
Support SMM region in initiatives/activities as agreed with Line Manager (SMM Director/CRM).
Minimum Requirements
Bachelor's Degree preferable in the Life Sciences
3 + years’ experience in Clinical Operations or other related fields (Medical Affairs-led studies or Academic-led studies)
Excellent knowledge of spoken and written English.
Ability to learn and to adapt to work with IT systems.
AstraZeneca Values
We follow the science
We put patients first
We play to win
We do the right thing
We are entrepreneurial
