Local Trial Manager Job at iconplc (Warsaw)

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

Country Study Operations Manager I - FSP

Key Accountabilities: Study Management Oversight; Study Management Operations; S...

Location

Turkey

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
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
Demonstrated experience in managing country level operational activities and/or vendors
Experience in study and quality management
Knowledge of clinical trial methodology

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 be responsible and accountable for, as designated by the GSM: Regional, country and study level implementation of startup and site activation plans (through SUPM or pCRO if assigned)
Regional, country and study level recruitment strategy

Local Study Associate Director

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

Location

United States

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor degree in related discipline, preferably in life science, or equivalent qualification
Five years of US focused clinical trial management experience, including budget oversight
Good knowledge of international guidelines ICH- GCP as well as relevant local regulations
Excellent project management skill
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

Job Responsibility

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality
Leads and optimizes 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 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 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 SOPs

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

Clinical Trial Manager

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

Location

Brazil , Sao Paulo

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree in medicine, science, or equivalent combination of education & experience
Demonstrated experience to drive the clinical deliverables of a study with GLOBAL scope
Based in Brazil
Fluent English

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

Clinical Trial Manager

CTM (Sr.) All Level-Home Based-South Korea. ICON plc is a world-leading healthca...

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
Ability to travel up to 20%

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, among others

Fulltime

Legal Assistant

We are looking for a skilled Legal Assistant to join our team in Little Rock, Ar...

Location

United States , Little Rock

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Proficiency in e-filing and court filings with a strong understanding of local and state court rules
Demonstrated ability to manage attorney calendars and schedule legal proceedings
Skilled in drafting and dictation for legal correspondence and documents
Experience in handling personal injury cases or similar legal matters
Strong organizational skills for tracking and managing legal records and case files
Effective communication abilities to interact with clients, insurance adjusters, and opposing counsel
Familiarity with case management systems and maintaining detailed case notes
Ability to assist with trial preparation, including document organization and exhibit preparation

Job Responsibility

Conduct initial client intakes to gather case details and open new files
Organize and track medical records, bills, police reports, and insurance documents
Draft demand letters, settlement packages, discovery responses, and other legal documents related to personal injury cases
Provide regular updates to clients and collect necessary information through consistent communication
Coordinate with insurance adjusters, medical providers, opposing counsel, and court staff
Manage attorney schedules, including arranging depositions, mediations, and medical examinations
Assist with e-filing court documents while ensuring compliance with applicable court rules
Maintain detailed case notes and update relevant case management systems
Support trial preparation by organizing exhibits, medical chronologies, and witness lists
Facilitate the negotiation and processing of medical liens and subrogation claims as needed

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

Fulltime

Senior Clinical Research Manager - Network Operations

The Senior Clinical Research Manager (CRM) provides strategic and operational ov...

Location

United States , Brookline; Brighton; Milford; Weymouth; Methuen; Foxborough; Londonderry

Salary:

105400.00 - 130500.00 USD / Year

Dana-Farber Cancer Institute

Expiration Date

Until further notice

Requirements

Bachelor’s Degree required, with a minimum of 7+ years of related experience or Master Degree with 5+ years experience.
Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
Experience in protocol development, data compilation and analysis.
Skilled at developing tracking systems to ensure timely data management by the clinical research staff.
Expert knowledge of Federal and State regulations as they relate to research.
Strong interpersonal, organizational and communication skills are required.
Must have computer skills including the use of Microsoft Office and working knowledge of Livelink
EPIC and OnCore applications.
Has expert knowledge of and is fully proficient in ability to execute clinical trials start-up, active and close out phases.
Is fully proficient in their knowledge of clinical research local policy and federal regulation.

Job Responsibility

CLINICAL TRIAL OPERATIONS: Responsible for the oversight of their disease group's clinical trial portfolio and all related regulatory, compliance and performance metrics requirements.
Oversee the processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) when appropriate.
Collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS) and the Quality Assurance for Clinical Trials (QACT) to fulfill local and federal requirements governing human clinical trials.
Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
Assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.
Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
Work collaboratively with clinical research administration and grant managers to help monitor and reconcile all study and related grant finances as needed.
Assists the principal investigator in preparing manuscripts for publication.
Collaborate with the DFCI CTO and DF/HCC QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials
Oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients.

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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