Clinical Trial Administrator Job at Randstad (Biberach an der Riß)

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
Customs Clearance : Mandatory requirement

Job Responsibility

Assist in the coordination and administration of clinical trials, ensuring compliance with protocols and regulatory requirements
Maintain and organize clinical trial documentation, including study files, essential documents, and regulatory submissions
Support the preparation of study-related materials, such as informed consent forms and case report forms
Work with cross-functional teams to facilitate communication and ensure smooth trial execution
Contribute to the tracking and reporting of clinical trial metrics and milestones

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 Trials Assistant - FSP

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

Australia , North Ryde, Sydney, Macquarie Park

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Adaptable
Communicator
Collaborative
Leadership
Proactive
Problem-solver

Job Responsibility

Clinical trial related general tasks as required throughout the trial life cycle
Communicate internally with clinical trial team (e.g., CTM, CRA) and externally with clinical sites, vendors and other departments
Set up and maintenance of trial related sharing platforms e.g., Sharepoint Online
Support trial document management processes for Clinical Documentation System (Veeva Clinical, Clinergize etc) including TDS communication of document event date, document submission, quality check/resolution and set up & maintenance of paper TMF documentation/filing and arrangement of long-term archiving process if required
Coordinate clinical trial related document translation process
Support trial related documents verification
Support trial document creation & filing process e.g., local clinical trial protocol amendment, local signature page etc.
Support CTM for the site ISF archival, if locally required to use external archiving vendor
Support RA/EC submission e.g., CTR relevant as applicable
Support updates of clinical trial related information into Clinical Trial Management System (e.g., Veeva Clinical)

What we offer

Supportive work environment
High degree of empowerment and accountability
Work with a diverse set of clients and therapeutic areas
Encouraged to take on new challenges and pursue your interests
Supportive and inclusive environment
Flexible work arrangements
Remote, in-office and hybrid roles
Varied project experience
Career progression

Clinical Trial Manager

Clinical Trial Manager - Early Oncology

Location

United States , CARY, BLUE BELL, BASKING RIDGE, NJ, CHICAGO, IL

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree with at least 3 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience
Must have strong knowledge of ICH/GCP guidelines and regulatory requirements
Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
Requires project management skills and trial leadership ability
Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
Fluent in English
Experience in Phase I oncology
Global experience with primary focus on independent vendor set up and management, oncology cohort management and experience in supporting dose escalation safety meetings.

Job Responsibility

Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
Leads or supports cross-functional trial teams, including vendors
Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders
Proactively identify and resolve issues that arise during trial conduct
manage escalation of trial-related issues
Participate in or lead the development of core trial documents, trial plans and system set-up
participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data
Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors
effectively manage interactions and escalations with vendor trial team
Participate in or lead feasibility assessment and selection of countries and sites for trial conduct

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.