Local Study Manager [Netherlands]

 

To 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), the Local Study Associate Director (LSAD) may perform site monitoring as
needed to support the flexible capacity model.
The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated,
monitored, closed and documentation archived.

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 optimises 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.

• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of

the study. Works together with Regulatory Affairs to ensure timely delivery of
application/documents for submissions to Regulatory Authority for the duration of 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 Director, SMM/ Director, Country Head.

• 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 sitesready to enrol, 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 pro-actively advices the

monitor(s) on study related matters.

• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organises 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 Associate Director/ 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 co-ordinates regularly with National Co-ordinating 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 organised 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

• 
  +3 years of CRA experience
• good PM skills
• fluent in dutch and english
• open to go to Den Haag 2x/week

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