Local Trial Manager Job at iconplc (Warsaw)

New

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

New

Local Clinical Trial Manager/Country Trial Manager - FSP

Parexel are currently recruiting for an experienced Local Trial Manager/Country ...

Location

Germany

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 5 years of relevant clinical trial management experience
Experience managing outsourced trials or CRO Management
Vendor Management experience
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

Job Responsibility

Verify the trial is conducted in compliance with GCP-ICH, local/global regulations, application SOPs and according to the trial protocol by overseeing CRO and internal team activities
Creation, management, and review of the trial budget to verify appropriate level of financial oversight and planning accuracy
Appropriate trial-specific training of internal and external partners is performed in line with trial training plan
Accurate planning and co-ordination of operational feasibility of trial timelines and oversight of trial preparation to verify trial team members are aligned and on track
Verifies and provides input into the country and site level feasibility and commitment
Development and implementation of country level engagement plans, recruitment planning and risk mitigation
Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders
Maintains oversights during clinical trial conduct including adherence to GCP and all global and local regulatory requirements
compliance with SOPs and continuous risk monitoring /mitigation

Fulltime

Senior Clinical Associate

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

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

At least Bachelor degree
At least 2 years of experience as CTA (working for Pharmaceutical or CRO company)
Planning and organizational skills
Advanced communication skills

Job Responsibility

Adhere to applicable SOPs WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
Comply with relevant training requirements
Assist in trial specific document management, including finalization, distribution, and document revision management and archiving, with a strong focus on inspection readiness
Assist in IP and ancillary supply management, including ordering, distribution, and tracking
Ensure the current trial status and tracking of trial related information is available at all times in the appropriate Clinical Trial Management System(s) (CTMS) and/or tracking tools
Ensure trial specific data are up-to-date, complete, and accurate during all phases of the trial in collaboration with CRO, Local Trial Managers and Site Managers
Ensure trial delivery according to the agreed upon timelines/milestones by conducting supportive trial coordination activities and tracking of trial timelines and deliverables
Run data & metric reports in support of trial deliverables
Responsible for review/management of Trial Master File (TMF) for completeness and timely provision
Maintain key trial specific information, including trial contact list

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 maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Quality Compliance Manager

The Quality Compliance Manager will lead the implementation of a customized, ris...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in appropriate discipline or equivalent (e.g.: Biomedical Science / Nursing etc.)
Minimum 5 years in pharmaceutical industry and good in-depth knowledge of ICH GCP standards
2 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or TrackWise
Thorough understanding of Clinical R&D activities and Global/local Regulations
Knowledge of Regulatory Submission and local/Foreign Inspection Management procedures
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
Excellent verbal and written communication skills, including strong business writing abilities and active listening
Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format
Strong analytical, critical-thinking, and decision-making abilities

Job Responsibility

Review clinical trial protocols to ensure simplification, integration of lessons learned, and identification of critical data and processes
Provide quality oversight by assessing trial risks using the Risk Assessment Categorization Tool (RACT), ensuring accurate prioritization and mitigation of risks to patient safety, data integrity, and regulatory compliance—including country-specific risks relevant to Taiwan
Lead the development and implementation of Taiwan-specific Quality Plans, establishing local expertise to ensure adherence to applicable regulations
Collaborate with Clinical Quality Therapeutic Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarkers, imaging)
Contribute to the design and execution of TA and affiliate-specific Quality Assurance plans, including audit strategies (e.g., investigator site, affiliate, and study-level audits)
Support local clinical trial and cross-functional teams in managing quality activities such as issue resolution (e.g., deviations, CAPAs, serious breaches, privacy concerns), inspection readiness, and audit/inspection management
Monitor, analyze, and report compliance metrics and trends to key stakeholders and senior leadership, providing actionable recommendations
Drive innovation by exploring and applying sophisticated quality oversight methodologies, including AI, Natural Language Processing (NLP), and data analytics

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

Home-based Client Dedicated Program CTM position. As a Clinical Trial Manager at...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

2+ years of Local or Global SIT CTM experience including MVR review, direct contact with Study Lead, vendor communications and meeting hosting
Bachelor’s degree
Fluent English
Demonstrated ability to drive the clinical deliverables of a study
Subject matter expertise in the designated therapeutic area

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
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

Fulltime

Clinical Trials Regulatory Submission Senior Associate

In this vital role you will be responsible for performing Regulatory submissions...

Location

Argentina , Buenos Aires

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
OR Bachelor’s degree and 5 years of Clinical Trials experience
Minimum 3 years of regulatory submissions and/or study start-up experience is required with strong technical knowledge performing Clinical Trial Applications in Argentina (ANMAT, CCIS)
Excellent written and verbal communication skills in English
Experience and/or technical knowledge in Import License extensions is a strong plus
Ability to plan, develop, and manage timelines, including keeping them up to date
Comfortable managing multiple projects and priorities at the same time
Skilled at building and maintaining positive relationships with health authorities, colleagues, managers, and service providers
Able to work independently and asynchronously across time zones in a collaborative, matrixed team environment

Job Responsibility

Performing Regulatory submissions in Argentina to ANMAT/ CCIS
Compiling submission dossier
Execution of all regulatory activities for clinical trial projects and programs, according to local regulations and Amgen’s policy
Interacting directly with Functional Service Providers for Ethics Committee Services, Clinical Project Management (Local Trial Managers), Global Study Operations, International Regulatory Team, CMC Global Product Leads, Pharmacovigilance, Clinical Supply Chain and vendors acting as Importer of Record
Performing efficiently end-to-end Clinical Trials Regulatory submissions in country for new and ongoing project(s) or programs
Submitting, with the input of importer of record, study specific import licenses extensions until approvals
Communicating overall regulatory status to internal teams and service providers
Attending to project meetings with cross functional department leads to provide regulatory timelines and requirements for regulatory submissions and approvals
Collaborating with internal team members to establish timelines and clarify regulatory requirements
Maintaining clinical trial regulatory requirements' database, including regular updates to checklists

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Country Study Operations Manager - FSP

Parexel FSP is looking for multiple Country Study Operations Manager I! Candidat...

Location

Mexico

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's of Science or Bachelor's of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
Master's of Science or Master's of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
A scientific or technical degree is preferred
Fluency in written and spoken English required
Ability to work outside of core business hours, as required, to support global trials or initiatives
Ability to travel, as required, including Investigator Meetings, vendor kick off and re-set meetings, and client internal global or department level meetings
Comprehensive knowledge of own discipline with good knowledge of other disciplines
Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team
Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility
Demonstrated clinical research experience and/or study management/startup project manager experience

Job Responsibility

Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables
Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies
Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
May manage the study start up process in countries assigned [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable
Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs)
Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM during planning
Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required
Accountable for resolution of site activation escalations to study teams including offering options for mitigation
May help guide the study management strategy by contributing local intelligence and providing accurate updates on delegated tasks to support establishment of critical path activities and risks
May independently take on activities with instruction provided as needed

What we offer

Benefits vary by country, but Parexel is passionate about our team's overall wellness

Fulltime

Local Trial Manager

iconplc

Location:
Poland , Warsaw

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 24, 2026

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Job Description:

Job Responsibility:

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Nice to have:

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Job Posted:January 24, 2026

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