Clinical Trial Manager - Sponsor Dedicated
- Greece
- ICON Strategic Solutions
- Clinical Trial Management
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
What you will be doing:
- Is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and GTM.
- Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
- Collaborates with the CPL, GTM, local management/Country Head and Protocol Owner to select final site list.
- Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial.
- Leads and coordinates local trial team activities in compliance with Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
- Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints). Uses study tools and management reports available to analyze trial progress
- Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams.
- May submit requests for vendor services and may support vendor selection.
- May lead negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines.
- Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting
- Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
- Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the GTM and FM as needed
- Reviews and approves site and local vendor invoices as required
- Works with SM to ensure CAPP is implemented for audits and inspection or any quality related visits
- Complies with relevant training requirements.
- Acts as local expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.
- Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.
- Actively contributes to process improvement; training and mentoring of Clinical Trial Administrators, Site Managers and other LTMs
You are:
- A minimum of a BA/BS degree is required.
- A degree in a health or science related field is preferred.
- Minimum two to four years of pharmaceutical and/or clinical trial management experience is preferred.
- Specific therapeutic area experience may be required depending on the position.
- Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements.
- Solid communication and computer skills required.
- Proficient in speaking and writing the country language and English language. Good written and oral communication skills
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- 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
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Teaser label
Career ProgressionContent type
BlogsPublish date
02/17/2023
Summary
Clinical Trial Managers and Clinical Project Managers are an integral part of the clinical market. Each role is essential in ensuring that clinical trials are well run and completed to a high stan
Teaser label
Career ProgressionContent type
BlogsPublish date
12/21/2022
Summary
Salary expectations used to be something discussed after an interview process but now it’s something most recruiters typically ask within the first conversation. This is to ascertain if the remune
by
Jamie Kempski
Who we are
Similar jobs at ICON
Salary
Location
Italy
Department
Clinical Trial Management
Location
Italy
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109212
Expiry date
01/01/0001
Author
Mattia CarcangiuAuthor
Mattia CarcangiuSalary
Location
United States
Department
Clinical Trial Management
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Trial Manager II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-110277
Expiry date
01/01/0001
Author
Melissa BennerAuthor
Melissa BennerSalary
Location
Italy
Department
Clinical Trial Management
Location
Italy
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
2024-110279
Expiry date
01/01/0001
Author
Mattia CarcangiuAuthor
Mattia CarcangiuSalary
Location
Spain, Madrid
Location
Warsaw
Barcelona
Madrid
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR117568
Expiry date
01/01/0001
Author
Katty Barreto MaiaAuthor
Katty Barreto MaiaSalary
Location
Spain, Madrid
Location
Barcelona
Madrid
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR119124
Expiry date
01/01/0001
Author
Lourdes Roy PratsAuthor
Lourdes Roy PratsSalary
Location
United States
Department
Clinical Trial Management
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Global Trial Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-110237
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica Hawkins