Local Study Associate Director - Sao Paulo, Brasil - AstraZeneca

AstraZeneca
AstraZeneca
Empresa verificada
Sao Paulo, Brasil

há 1 semana

Ana Silva

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Ana Silva

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Descrição
AstraZeneca is one of the most fascinating biopharmaceutical companies in the world.

From researchers to sales people, from lab technicians to the legal department, we all have a mission to turn ideas into science, science into revolutionary medicines that save and extend patients'; lives and benefit society.

Our portfolio is solid and our pipeline is innovative with a focus on biological medicines in the Cardio-Metabolic, Respiratory and Oncology areas.


Main accountabilities:


  • Has the overall responsibility for the study commitments within the country and for
timely delivery of data to required quality;

  • Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies;
  • Leads and optimizes the performance of the Local Study Team(s) at country level
ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations;

  • Ensures, as required, that clinical and operational feasibility assessment of potential
studies is performed to the highest quality;

  • Coordinates the site selection process by identifying potential sites/investigators,
performing initial Site Quality Risk Assessment and conducting Site Qualification Visits

to evaluate suitability and quality risks;

duration of the study. Works together with Regulatory Affairs to ensure timely delivery

the study, and in line with local regulations;

  • Ensures timely preparation of country financial Study Management Agreement (fSMA)
and maintains accurate study budget in AZ clinical studies financial system by regular

checks of the system and financial reports (as agreed with ADSMM/CH);

  • Ensures timely preparation of local Master CSA (including site budget) and
amendments as needed;

  • Ensures timely preparation of country level Master Informed Consent Form (MICF) and
subsequent site level ICFs, as required, including any relevant translations, and in line

with relevant AZ SOPs and local regulations;

  • Ensures all country and site level trial essential documents required by ICH-GCP prior
to study start have been collected and verified for correctness, prior to setting sites

ready to enroll, and in line with AZ SOPs;

  • Plans and coordinates applicable local drug activities (from local purchase or
reimbursement to drug destruction);

  • Sets up and maintains the study in CTMS at study country level as well as local
websites as required by local laws and regulations;

  • Oversees, manages and coordinates monitoring activities from site activation through
to study closure at country and site level in accordance with the Monitoring Plans;

  • Reviews monitoring visit reports (as required and following AZ SOPs) and proactively
advices the monitor(s) on study related matters;

  • Performs any required comonitoring, Accompanied Site Visits/training visits with
study CRAs;

  • Proactively identifies risks and facilitates resolution of complex study problems and
issues;

  • Organizes regular Local Study Team meetings on an agenda driven basis;
  • Actively works towards achieving good personal relationships with all Local Study
Team members, sites' staff and global stakeholders;

  • Reports study progress/update to the Global Study Leader/ Global Study Team
including SMM Lead;

  • Contributes to patient recruitment strategy including regular communication with
participating Investigators as necessary;

  • Develops, maintains and reviews risk management plan on country study level:
proactively manages sites, stakeholders, local and global vendors and customers to

ensure risks are timely identified, mitigated and managed;

  • Communicates and coordinates regularly with National Coordinating Investigator /
National Lead Investigator on recruitment and other study matters, if applicable;

  • Plans and leads National Investigator meetings, in line with local codes, as required;
  • Assists in forecasting study timelines, resources, recruitment, budget, study materials
and drug supplies;

  • Ensures relevant systems required to facilitate business critical, license to operate
activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial

Transparency) are set-up, updated and access is organized at country level;

  • Ensures accurate payments related to the study are performed according to local
regulations and agreements;

  • Participates in training and coaching new members of the Local Study Team ensuring
compliance with ICH-GCP and AZ Procedural Documents;

  • Ensures completeness of the eTMF and ensures essential documents are uploaded in
a timeline manner to maintain the eTMF "Inspection Ready";

  • Ensures that all study documents are ready for final archiving and completion of local
part of the eTMF;

  • Plans and leads activities associated with audits and regulatory inspections in liaison
with CQM and QA;

  • Provides input to process development and improvement;
  • Provides regular information to Line Managers (AD SMM/CH SMM) at country level on
study/ies and planned study milestones/key issues;

  • Updates Li
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