Clinical Associate - CTA Job at iconplc (Blue Bell)

Clinical Trial Associate 3 (CTA 3)

As a SMA II at ICON, you will support the management and monitor of clinical tri...

Location

Mexico , Mexico City

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field such as life sciences, healthcare administration, or clinical research
Experience in clinical research, site management, or monitoring, with a solid understanding of clinical trial processes and GCP guidelines
Strong organizational and project management skills, with the ability to handle multiple priorities and deadlines
Excellent analytical skills and attention to detail, with a focus on maintaining high-quality standards
Exceptional communication and interpersonal skills, with the ability to build and maintain effective relationships with site personnel and cross-functional teams
Willingness to travel as required (approximately 25%)

Job Responsibility

Coordinating monitoring activities at clinical trial sites, ensuring adherence to study protocols and timely resolution of site-related issues
Assisting in the preparation and review of regulatory documents, ensuring all site activities are compliant with GCP and applicable regulations
Collaborating with cross-functional teams to facilitate effective communication and support for trial sites throughout the study lifecycle
Tracking site performance metrics, analyzing data, and providing reports to enhance site management efficiency
Participating in training initiatives and mentoring junior staff to support their development in clinical trial 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 Regulatory Affairs Associate - Clinical Trial Applications (CTA)

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

South Africa , Bloemfontein

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a science discipline
Background in clinical trial management
Innitial years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa - must
Experience with clinical trial submissions in other Southern African Countries - preferred
Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization
IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
Solid analysis and synthesis capability
Solution-oriented and problem-solving skills
Customer-oriented and autonomous
Fluency in English is a must along with the local language.

Job Responsibility

Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead
Regulatory submission of Clinical Trial in South Africa
Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary
May be involved in local, regional, and/or global projects

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

New

Clinical Research Associate I

As a CRA I at ICON, you will contribute to our clinical trial operations functio...

Location

Argentina , Buenos Aires

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree in medicine, science, or equivalent
Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data
Experience in Clinical Research as CTA or similar roles
Excellent written and verbal communication in English
Good social skills enabling you to deal with queries in a timely manner
Willingness to travel as required (approximately 60%)
Based in CABA

Job Responsibility

Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation
Running sponsor generated queries efficiently and taking responsibility for study cost efficiency
you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required
Develop and maintain strong, collaborative relationships with key stakeholders, clinical investigators, and site staff
Ensure patient safety by ensuring compliance with ICON's procedures, protocols, and regulatory requirements

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

SSU Clinical Research Associate II

As a CRA II at ICON, you will design and analyse clinical trials, interpreting c...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Minimum of 2 years of experience as a Clinical Research Associate
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
Ability to work independently and collaboratively in a fast-paced environment
Willingness to travel as required (approximately 60%)

Job Responsibility

Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process
Collaborating with investigators and site staff to facilitate smooth study conduct
Performing data review and resolution of queries to maintain high-quality clinical data
Contributing to the preparation and review of study documentation, including protocols and clinical study report
Site selection visit
Startup study set up before SIV
Country ICF development, site ICF review/approval
Ongoing study review for IRB, ICF amendment task (CTA draft/submission)

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

Senior Clinical Trial Associate

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

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Prior experience or strong interest in clinical research
Knowledge of clinical trial processes, regulations, and guidelines
Excellent organizational and communication skills
Ability to work collaboratively in a fast-paced environment with attention to detail
이전 CRA 경험 혹은 CTA 경험 required
Flexibility, Ownership 있으신분

Job Responsibility

치료목적 사용 승인 프로그램: Provision of access to an investigational or locally unapproved or locally unavailable (not launched* in the country of request) product outside of clinical trials to address an unmet medical need
다른 의학적인 옵션이 없는 상태에서, 심각한 혹은 생명을 위협하는 질환을 가진 환자들에게 임상시험용 의약품(IMP)의 허가 및 시판 전 약물 공급 및 접근을 제공
MAP status 시스템 내에서 관리
Essential Document 관리
비용관리
임상약 관리
Safety 관련 check 및 distribution, SAE reconciliation

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

Regulatory Affairs Manager

The Regulatory Affairs Manager at Amgen ensures the company’s compliance with al...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate Degree
Master's Degree and 3 years of Regulatory CMC or related technical experience
Bachelor's Degree and 5 years of Regulatory CMC or related technical experience
Associates degree and 10 years of Regulatory CMC or related technical experience

Job Responsibility

Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
Support development of global dossiers for CMC content of new marking applications (MAA), new clinical trials (CTA), variations and amendments to existing MAA/ CTAs
Development of post-approval submissions including maintenance of applications
Support Change Management activities
Respond to regulatory agency questions
Liaise with the Global RA CMC product lead, ROOTS representatives, and other functions in development, operations, and commercial to ensure alignment of global regulatory strategies and timing, execution
Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current
Participate as an active member of cross-functional teams

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

Site Management Associate II

As a Site Management Associate II (SMA II) at ICON, you will support the managem...

Location

Argentina , Buenos Aires

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in health sciences or administrative programs
At least 3 years relevant experience /strong understanding of the scope of clinical trial administration
Advanced English
Leadership skills and great potential for development
Proactive, organized, tech savvy, attentive to details

Job Responsibility

TMF filing, quality, maintenance, compliance, and oversight
Lead the development and delivery of sites’ ISF, and eISF when utilized, and act as primary point of contact for the sites and manage the Site Operations/monitor access to eISF prior to SIV
Maintain Registries and systems as required
Support of site payment services, patient compensation services and other local payments as required
Provide reporting to support management of clinical trials
Provide support with audit and inspection readiness activities
Lead regional activities within the team and the client
Provide support to CTA managers for development and implementation of on-boarding training for new hires: Mentor new hires and entry level CTAs
Serve as SME for key CTA processes, systems and tasks
Work with CTA managers to identify continuous improvement opportunities to enhance operational efficiencies

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

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Clinical Associate - CTA

Job Description

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