Local Trial Manager Job at iconplc (Warsaw)

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

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.

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

Regulatory Affairs Manager

In this vital role you will work to ensure that Amgen acquires and maintains all...

Location

United Kingdom , Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Scientific Degree and demonstrated experience in a similar role
Regulatory principles
Working with policies, procedures and SOP’s
Knowledge of legislation and regulations relating to medicinal products
Awareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals.
Knowledge of drug development
Knowledge of and experience in regional regulatory environment
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues

Job Responsibility

Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
Provide content guidance for regional regulatory documents and meetings in accordance with global strategy
Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)
Support regional label negotiation activities
Under general supervision participate in the development, and execution of regional regulatory product strategies
Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies
Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
Under supervision evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling

What we offer

Growth 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

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

New

Regulatory Coordinator - Thoracic Oncology

The Regulatory Coordinators (RC) works under the direction of the Thoracic Oncol...

Location

United States , Brookline

Salary:

55530.00 - 61700.00 USD / Year

Dana-Farber Cancer Institute

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or 1 year of Dana-Farber Associate Regulatory Coordinator experience required
0-1 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred
Fundamental knowledge of the conduct of clinical trials is preferred
Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills
Demonstrated organization and time management/prioritization skills with the ability to work independently are required
Must be proficient in the use of computers, Microsoft applications and databases
Requires experience with medical terminology
Must be able to perform day to day responsibilities duties as described above with regular and ongoing training and supervision
Attains and can demonstrate fundamental knowledge and is somewhat proficient in some or all of the following areas: DFCI, DF/HCC, ICH/GCP, FDA policy / guidance / regulation
an understanding of the IRB submission & approval process

Job Responsibility

Regulatory Compliance: Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval
Prepares and submits regulatory documentation that may include
IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA), etc
Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement
Industry sponsor, DF/HCC sponsored etc
Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion
Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC ODQ, Industry Sponsors, and third-party auditors
Leadership and Professionalism: Maintain working knowledge of current regulations, regulatory guidance and or local policies
Assists Clinical research Manager with regulatory based training and implementation of new or revised regulation, guidance and or local policy
Present regulatory status for disease group portfolio at applicable research meetings

Fulltime

Senior Clinical Research Associate

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Taiwan , Taipei

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Sound problem solving skills
Able to take initiative and work independently, and to proactively seek guidance when necessary
Advance presentation skills
Client focused approach to work
Ability to interact professionally within a client organization
Flexible attitude with respect to work assignments and new learning
Ability to prioritize multiple tasks and achieve project timelines
utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise

Job Responsibility

Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues
Build relationships with investigators and site staff
Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements
Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant
Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication
Address/evaluate/resolve issues pending from the previous visit, if any
Follow-up on and respond to appropriate site related questions
Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action
Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required
Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

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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