JUMP TO CONTENT

LSAD

  1. Budapest
2024-115059
  1. ICON Strategic Solutions
  2. Clinical Trial Management

About the role

 

To lead Local Study Team at country level to deliver committed components of clinical studies
according to agreed resources, budget and timelines complying with  Procedural Documents,international guidelines such as ICH-GCP as well as relevant local regulations.

In addition to leading , the Local Study Associate Director  may perform site monitoring asneeded 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  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  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 sites ready 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”.


Bachelor degree in related discipline, preferably
in life science, or equivalent qualification (*).
• Minimum 3 years of experience in Development
Operations (CRA, SrCRA) or other related fields
(Medical Affairs-led or Academic-led studies).
• Good knowledge of international guidelines ICHGCPaswell as relevant localregulations.
• Proven ability to lead and motivate crossfunctional

teams to deliver clinical trials  according to or ahead of time plan, budget andwith required quality.
• Excellent project management skills.
• Excellent team building and interpersonal skills.
• Excellent organisational skills.
• Excellent verbal and written communication
skills.
• Excellent ability to prioritize and handle multiple
tasks.
• Excellent attention to details.
• Excellent knowledge of spoken and written
English.
• Good negotiation skills.
• Good ability to learn and to adapt to work with
IT systems.
• Ability to travel nationally and internationally as

  • #LI-Onsite

    #LI-OB1

 

 

List #1

Day in the life

Man with headphones on looking at a laptop
Tips to make a lasting impression in a video interview

Teaser label

Career Progression

Content type

Blogs

Publish date

05/10/2024

Summary

Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv

Teaser label

Ace your virtual job interview with these proven video interview tips.

Read more
A picture of Debora Oh
How to excel as a CRA in a Clinical Research Organisation

Teaser label

Our People

Content type

Blogs

Publish date

08/29/2023

Summary

To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her

Teaser label

Brazil-based CRA II Debora Oh shares her tips on how to become a great CRA and provides insight into life at ICON.

Read more
women working on a laptop
What is the difference between a clinical trial manager and a clinical project manager?

Teaser label

Career Progression

Content type

Blogs

Publish date

02/17/2023

Summary

Clinical Trial Managers and Clinical Project Managers are an integral part of the clinical market. Each role is essential in ensuring that clinical trials are well run and completed to a high stan

Teaser label

And which role is right for you?

Read more
View all

Similar jobs at ICON

Implementation Manager

Salary

Location

Sofia

Department

Clinical Trial Management

Location

Sofia

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

As a Clinical Implementation Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2024-115143

Expiry date

01/01/0001

Dariusz Sternlicht Read more Shortlist Save this role
Site Engagement Liaison

Salary

Location

Australia

Department

Clinical Trial Management

Location

Australia

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

Site Engagement LiaisonLocation: Sydney/ Melbourne (home-based) As a Site Engagement Liaison, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by he

Reference

2024-115195

Expiry date

01/01/0001

Krisztina Auth Read more Shortlist Save this role
Clinical Team Operations Leadership (Program Manager) - Home Based (US

Salary

Location

United States

Department

Clinical Trial Management

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

As a CTOL (Program Manager) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2024-115051

Expiry date

01/01/0001

Brandon Pupek

Author

Brandon Pupek
Read more Shortlist Save this role
ECOA Project Manager

Salary

Location

United Kingdom, Spain, Netherlands, Poland

Department

Clinical Trial Management

Location

Netherlands

Poland

Spain

UK

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

As a ECOA Solutions Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. ICON plc is a world-leading healthc

Reference

2024-114654

Expiry date

01/01/0001

Rajvir Samra

Author

Rajvir Samra
Read more Shortlist Save this role
Clinical Trial Manager II

Salary

Location

United States

Department

Clinical Trial Management

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2024-115095

Expiry date

01/01/0001

Jonathan Holmes Read more Shortlist Save this role
Risk Based Study Manager - Home-Based

Salary

Location

United States

Department

Clinical Trial Management

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

As a Risk Based Study Manager/Monitor you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2024-114856

Expiry date

01/01/0001

Read more Shortlist Save this role

Browse popular job categories below or search all jobs above