Senior Clinical Trial Assistant Job at iconplc

Senior Clinical Trial Assistant

We are looking for an experienced, highly self-driven Senior Clinical Trial Assi...

Location

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Minimum 5 years’ experience as a Clinical Trial Assistant (senior level preferred)
Strong experience in biotech/pharma on the Sponsor side
CRO experience may also be suitable if you have clear sponsor-oversight exposure and strong TMF responsibility
Demonstrated ability to work independently, proactively and with strong ownership in an agile setting
Deep hands-on experience with TMF/eTMF, QC/completeness, and an “inspection readiness” mindset
Strong organisational skills, attention to detail, and confident stakeholder management
Fluent in English, written and spoken
Bachelor’s/Master’s degree or similar academic background (strongly preferred)

Job Responsibility

Provide comprehensive administrative and operational support to a clinical team (internal team plus external consultants)
Proactively set up, maintain and quality-check the Trial Master File (TMF/eTMF) for two new Phase 2 trials
Support final Phase 1 close-out and archiving activities
Coordinate end-to-end document flow (drafting support, version control, review cycles, approvals, signatures and filing)
Track deadlines, milestones and deliverables
follow up on overdue items and escalate when needed
Support two Senior Trial Managers with day-to-day execution, meeting preparation, action logs and follow-through
Help ensure all clinical operations processes follow applicable standards and expectations (incl. ICH-GCP)

What we offer

Competitive compensation reflecting seniority and experience
Significant flexibility, including the option of reduced hours (e.g., 80% / 3-day week) and a flexible remote work policy
A unique opportunity to join a small, close-knit, international team where your contribution is highly visible
Work on cutting-edge clinical development in an ambitious biotech environment
A culture that values stability, long-term collaboration, and retention of top talent

Fulltime

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 Manager

Sr Local Trial Manager – Solid Tumor Oncology - Home Based (US) ICON plc is a wo...

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
Solid Tumor Oncology 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
Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate
To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
Collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
Focuses on investigator engagement through timely follow up with sites
Promptly communicates relevant status information and issues to appropriate stakeholders
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress
When necessary initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance team

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 Clinical Trial Specialist

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

Advanced degree or certification in a relevant field such as life sciences, healthcare, or clinical research
Extensive experience in a clinical trial support role, with a solid understanding of clinical trial processes and regulatory requirements
Strong organizational and multitasking skills, with the ability to manage multiple tasks and projects effectively
Proficiency in clinical trial management systems and relevant software, with a keen eye for detail in documentation and data management
Excellent communication, interpersonal, and problem-solving skills, with the ability to work collaboratively with diverse teams and stakeholders

Job Responsibility

Providing administrative support for clinical trials, including managing documentation, coordinating meetings, and maintaining trial-related records
Assisting in the preparation and submission of regulatory documents and ensuring compliance with study protocols and regulatory requirements
Collaborating with cross-functional teams to support trial operations and resolve any issues that arise during the course of the study
Monitoring and tracking trial progress, including managing site communications and ensuring timely delivery of study materials
Building and maintaining strong relationships with site staff and other stakeholders to facilitate smooth trial operations and support overall project success

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 Specialist

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

Advanced degree or certification in a relevant field such as life sciences, healthcare, or clinical research
Extensive experience in a clinical trial support role, with a solid understanding of clinical trial processes and regulatory requirements
Strong organizational and multitasking skills, with the ability to manage multiple tasks and projects effectively
Proficiency in clinical trial management systems and relevant software, with a keen eye for detail in documentation and data management
Excellent communication, interpersonal, and problem-solving skills, with the ability to work collaboratively with diverse teams and stakeholders

Job Responsibility

Providing administrative support for clinical trials, including managing documentation, coordinating meetings, and maintaining trial-related records
Assisting in the preparation and submission of regulatory documents and ensuring compliance with study protocols and regulatory requirements
Collaborating with cross-functional teams to support trial operations and resolve any issues that arise during the course of the study
Monitoring and tracking trial progress, including managing site communications and ensuring timely delivery of study materials
Building and maintaining strong relationships with site staff and other stakeholders to facilitate smooth trial operations and support overall project success

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 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

Senior Clinical Study Associate

Be the backbone of clinical research-join a team shaping tomorrow's therapies. P...

Location

United States , Cambridge

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong understanding of clinical trial processes and regulatory requirements
Experience with TMF management and document tracking
Proficiency in managing laboratory vendors and coordinating sample logistics
Ability to review and analyze site performance metrics and monitoring reports
Excellent organizational and communication skills
Familiarity with site contracts, budgets, and feasibility assessments
Ability to work collaboratively with cross-functional teams and external vendors

Job Responsibility

Oversee day-to-day clinical trial execution, including site start-up, patient enrollment, and monitoring
Support the Clinical Study Manager and team members in managing trial activities
Prepare study documents such as consent forms, site instructions, and study-specific materials (e.g., Manual of Operations, Pharmacy Binder)
Track essential documents, ensuring accuracy and proper filing in the Trial Master File (TMF)
Monitor patient status at investigative sites and ensure accurate tracking
Manage sample collection, laboratory testing schedules, and central laboratory reporting
Assist with laboratory vendor management and liaise with CROs and clinical trial sites for sample handling and result reporting
Review monitoring trip reports, track data query reports, and assess site visit metrics and performance
Participate in site initiation, routine monitoring, and close-out visits, including co-monitoring with CROs
Ensure data quality from clinical sites and assist in resolving subject eligibility and protocol deviation issues

Senior Clinical Research Associate & CRAII - FSP

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

Location

Turkey , Istanbul

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Excellent attention to detail
Good written and verbal communication skills
Good collaboration and interpersonal skills
Good negotiation skills
Proficient in written and spoken English language required
Fluency in local language(s) required
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Good knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Client Therapeutic Areas
Basic understanding of the drug development process

Job Responsibility

Contributes to the selection of potential investigators
Accountable for study start-up and regulatory maintenance (in some countries)
Trains, supports, and advises Investigators and site staff in study related matters
Confirms that site staff have completed and documented the required training appropriately
Actively participates in Local Study Team (LST) meetings
Contributes to National Investigators meetings
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
Drives performance at the sites
Updates CTMS and other systems with data from study sites
Manages study supplies, drug supplies and drug accountability at study site

What we offer

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

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Senior Clinical Trial Assistant

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