Local Trial Manager Job at iconplc (Warsaw)

Country Clinical Trial Manager / Local Trial Manager

Register your interest for future opening with us as a Local/Country Clinical Tr...

Location

Italy

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 5 years of relevant end to end clinical trial management experience
Experience with customization or localisation of patient facing documents is essential
Excellent leadership, communication, and organizational skills. Able to multi-task under limited direction and on own initiative
M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential
Prior and demonstrable experience working at a senior level within Study start up preferred

Job Responsibility

Regional/Country/Study level implementation of Start-up and Site Activation Plans
Responsible for country/study level Recruitment Strategy
Responsible to support the development of study level plans
Communication with the local team and internal stakeholders and CRO partner as applicable and as listed above to ensure efficient and timely study delivery of the agreed plans
Responsible for study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
The Country Study Operational Manager will be able to work independently and exercise their own judgement

Senior Local Trial Manager - Oncology

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Start-up & Database Locks/Cleaning experience preferred
Oncology Solid Tumor experience required
Specific therapeutic area experience may be required depending on the position
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Willingness to travel with occasional overnight stay away from home according to business needs
Proficient in speaking and writing the country language and English

Job Responsibility

Ensuring top-quality end-to-end trial delivery at a country level
Managing the consistency of Local Trial Management duties and processes
Serving as the country-level single point of contact on the study for internal partners
Managing and overseeing Central IRB and other local vendors
Execution of local milestones from feasibility through study close out
Resourcing of country-level roles
Inspection Readiness and AQR at the country level
Close collaboration with assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers
Efficient communication with Clinical Trial Managers, Clinical Operations and Global Trial Leader
Country level ad hoc meetings during any phase of the study

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Local Trial Manager - Oncology/Hematology

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
2 years of local trial management or mutually agreed clinical trial experience
Start-up & Database Locks/Cleaning experience preferred
Oncology hematology experience required
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Willingness to travel with occasional overnight stay away from home according to business needs
Proficient in speaking and writing the country language and English
Good written and oral communication skills as appropriate

Job Responsibility

Accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes
Serve as the country-level single point of contact on the study for internal partners
Manage and oversee Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.…) including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable
Execution of local milestones from feasibility through study close out
Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM)
Inspection Readiness and AQR at the country level
Close collaboration with the assigned Local Trial Manager(s) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and provide support and training, where necessary
Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to oversee trial excellence
Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables
Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

LSOM Line Manager (Local Study Operations Line Manager)

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of clinical execution experience OR Master’s degree & 6 years of clinical execution experience OR Bachelor’s degree & 8 years of clinical execution experience OR Associate’s degree & 10 years of clinical execution experience OR High school diploma / GED & 12 years of clinical execution experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Job Responsibility

Lead the skill development of Local Study Operations Managers, ensuring effective trial implementation within the country and strong alignment with global strategies
Oversee the delivery of the country’s study portfolio—managing scope, timelines, and budgets—through the leadership of LSOM
Working in close partnership with the Country GSSO Head, help foster, enhance, and sustain an optimal clinical research environment that supports global R&D objectives
Drive alignment and continuous improvement in LSOM execution by integrating best practices, promoting digital innovation, and facilitating robust knowledge sharing across the team
Ensure the successful delivery of the study portfolio assigned to LSOMs
Oversee LSOMs’ fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close-out
Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution for LSOMs
Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country
Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials
Build and maintain a high-performing team

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Clinical Trial Manager

As a Clinical Trial Manager at ICON, you will manage clinical trial operations a...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree in medicine, science, or equivalent combination of education & experience
Demonstrated ability to drive the clinical deliverables of a study
Subject matter expertise in the designated therapeutic area
Prior monitoring experience is preferred
Willingness to travel as required (approximately 25%)

Job Responsibility

Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards
Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures
Build and manage strong relationships with trial investigators and stakeholders
Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines
Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Senior Clinical Trial Manager

Sr Local Trial Manager – Solid Tumor Oncology - Home Based (US). ICON plc is a w...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Start-up & Database Locks/Cleaning experience preferred
Solid Tumor Oncology experience required
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Willingness to travel with occasional overnight stay away from home according to business needs
Proficient in speaking and writing the country language and English
Good written and oral communication skills as appropriate

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Manages and oversees Central IRB and other local vendors including set up of vendor purchase orders, invoice review and approval, and change-orders
Execution of local milestones from feasibility through study close out
Resourcing of country-level roles, including support with transitions
Inspection Readiness and AQR at the country level
Close collaboration with assigned Local Trial Managers (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs)
Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL)
Country level ad hoc meetings during any phase of the study
Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Clinical Trial Manager

As a Clinical Trial Manager at ICON, you will manage clinical trial operations a...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree in medicine, science, or equivalent combination of education & experience
Demonstrated ability to drive the clinical deliverables of a study
Subject matter expertise in the designated therapeutic area
Prior monitoring experience is preferred
Willingness to travel as required (approximately 25%)
PMS/RMP CTM experience for at least more than 3 years

Job Responsibility

Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards
Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures
Build and manage strong relationships with trial investigators and stakeholders
Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines
Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Clinical Trial Manager

As a Clinical Trial Manager at ICON, you will manage clinical trial operations a...

Location

Italy , Milan

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree in medicine, science, or equivalent combination of education & experience
Demonstrated ability to drive the clinical deliverables of a study
Subject matter expertise in the designated therapeutic area
Prior monitoring experience is preferred
Willingness to travel as required (approximately 25%)
Location required is Milan and its surroundings since office attendance is required from time to time

Job Responsibility

Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards
Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures
Build and manage strong relationships with trial investigators and stakeholders
Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines
Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Select Country

Local Trial Manager

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?