Senior Clinical Trial Associate Job at iconplc (Reading)

Senior Clinical Trial Associate

Our client is looking to fill the role of CTA. The Senior Clinical Trial Associa...

Location

United States , San Diego

Salary:

35.00 - 48.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences or a related field preferred
Minimum of 3 years of clinical operations or clinical trial support experience
Experience supporting clinical studies within the biotechnology, pharmaceutical, medical device, or CRO industry preferred
Autoimmune experience required
Working knowledge of clinical trial processes, documentation, and GCP requirements
Strong organizational skills with exceptional attention to detail
Proficiency with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint
Strong written and verbal communication skills
Ability to manage multiple priorities and work effectively in a collaborative environment

Job Responsibility

Support day-to-day clinical trial operations across one or more studies
Maintain and organize Trial Master File (TMF) documentation and track essential study records
Monitor document status and communicate outstanding items to the study team
Track study metrics, enrollment, site activity, and clinical supply information
Assist with vendor, CRO, and site coordination activities
Support invoice tracking, reconciliation, and study budget administration
Identify and communicate study issues, risks, or operational concerns to the clinical team
Assist with review and management of study-related documents and materials
Ensure compliance with applicable regulations, GCP guidelines, SOPs, and study requirements
Perform additional clinical operations activities as assigned

What we offer

Medical
dental
401(k)
direct deposit
commuter benefits

Fulltime

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

Clinical Research Associate II / Senior Clinical Research Associate Large Pharma

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

Location

Germany , Frankfurt

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Master or 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
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools
Excellent communication skills in German and English
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license

Job Responsibility

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations

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 Research Associate or Clinical Research Associate II

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

Bachelor's degree in a scientific or healthcare-related field
Minimum of 1-year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior 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
Ability to travel at least 60% of the time (international and domestic - fly and drive)

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 reports

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 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 Associate Clinical Supply Chain – Global Clinical Customer Service (GCCS)

Reporting to the Manager, Development Supply Chain, you will support the global ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s Degree & 4+ years of supply chain, logistics, pharmaceutical operations, or related experience
OR Bachelor’s Degree & 5+ years of supply chain, logistics, pharmaceutical operations, or related experience
OR Associate’s Degree & 8+ years of relevant experience
OR High School Diploma / GED & 10+ years of relevant experience
Experience in clinical supply chain, pharmaceutical operations, or regulated operational environments
Strong problem-solving, issue resolution, and analytical skills
Ability to work effectively in a global, matrixed environment
Strong service-oriented mindset, responsiveness, and stakeholder support skills

Job Responsibility

Manage and resolve distribution complaints related to investigational product shipments supporting global clinical trials
Intake and triage Category-1 inquiries from clinical sites, study teams, and internal stakeholders
Coordinate cross-functional issue resolution and escalate risks appropriately
Review temperature data for investigational product shipments delivered to clinical trial sites
Perform temperature excursion assessments within Quality Management Systems following established procedures
Partner with Quality and study teams to support investigations, disposition decisions, and inventory status updates
Maintain accurate, complete, and inspection-ready documentation
Support study-level reconciliation activities to ensure accurate investigational product accountability
Manage investigational product returns in accordance with procedures and regulatory requirements
Support intake, documentation, and coordination of investigational product complaints

Fulltime

Senior Associate Clinical Supply Chain – Global Clinical Customer Service (GCCS)

Reporting to the Manager, Development Supply Chain, you will support the global ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's Degree & 4+ years of supply chain, logistics, pharmaceutical operations, or related experience
OR Bachelor's Degree & 5+ years of supply chain, logistics, pharmaceutical operations, or related experience
OR Associate's Degree & 8+ years of relevant experience
OR High School Diploma / GED & 10+ years of relevant experience
Experience in clinical supply chain, pharmaceutical operations, or regulated operational environments
Strong problem-solving, issue resolution, and analytical skills
Ability to work effectively in a global, matrixed environment
Strong service-oriented mindset, responsiveness, and stakeholder support skills

Job Responsibility

Manage and resolve distribution complaints related to investigational product shipments supporting global clinical trials
Intake and triage Category-1 inquiries from clinical sites, study teams, and internal stakeholders
Coordinate cross-functional issue resolution and escalate risks appropriately
Review temperature data for investigational product shipments delivered to clinical trial sites
Perform temperature excursion assessments within Quality Management Systems following established procedures
Partner with Quality and study teams to support investigations, disposition decisions, and inventory status updates
Maintain accurate, complete, and inspection-ready documentation
Support study-level reconciliation activities to ensure accurate investigational product accountability
Manage investigational product returns in accordance with procedures and regulatory requirements
Support intake, documentation, and coordination of investigational product complaints

Senior Associate Clinical Supply Chain – Global Clinical Customer Service

Reporting to the Manager, Development Supply Chain, you will support the global ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's Degree & 4+ years of supply chain, logistics, pharmaceutical operations, or related experience OR Bachelor's Degree & 5+ years of supply chain, logistics, pharmaceutical operations, or related experience OR Associate's Degree & 8+ years of relevant experience OR High School Diploma / GED & 10+ years of relevant experience
Experience in clinical supply chain, pharmaceutical operations, or regulated operational environments
Strong problem-solving, issue resolution, and analytical skills
Ability to work effectively in a global, matrixed environment
Strong service-oriented mindset, responsiveness, and stakeholder support skills

Job Responsibility

Manage and resolve distribution complaints related to investigational product shipments supporting global clinical trials
Intake and triage Category-1 inquiries from clinical sites, study teams, and internal stakeholders
Coordinate cross-functional issue resolution and escalate risks appropriately
Review temperature data for investigational product shipments delivered to clinical trial sites
Perform temperature excursion assessments within Quality Management Systems following established procedures
Partner with Quality and study teams to support investigations, disposition decisions, and inventory status updates
Maintain accurate, complete, and inspection-ready documentation
Support study-level reconciliation activities to ensure accurate investigational product accountability
Manage investigational product returns in accordance with procedures and regulatory requirements
Support intake, documentation, and coordination of investigational product complaints

Fulltime

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Senior Clinical Trial Associate

Job Responsibility

Requirements

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Senior Associate Clinical Supply Chain – Global Clinical Customer Service (GCCS)

Senior Associate Clinical Supply Chain – Global Clinical Customer Service

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