Clinical Trial Manager
- Czech Republic
- 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...
As a Local Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Local Trial Management services, provides local management of a clinical trial (or Medical Affairs data
generation activity) in a country or countries. Services/deliverables include operational oversight of assigned
protocol(s) at the country level from start-up through to database lock and closeout activities. Further, services
will ensure the local trial team is delivering quality data and trial documents/records that are compliant with
the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference
on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the Clinical
Trial Assistant (CTA)/lnvestigator Document Assistant (IDA), Site Manager (SM) and Central Trial Manager
(CTM)/Global Trial Manager to ensure overall study delivery at the country level.
Services rendered will adhere to applicable Johnson & Johnson SOPs, Wis, policies, codes of Good
Clinical Practice (GCP), local regulatory requirements, etc.
Complies with relevant training requirements.
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct
of pre-trial assessment visits and appropriate follow-up of pre-trial visit report and country feasibility
report. Collaborates with central study team 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. This may
require development of local trial specific procedures and tools, recruitment planning, contingency
and risk management, and budget forecasting.
Act as primary company contact for assigned trial at the country level, may attend/participate in
Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting.
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.
Contribute to site level recruitment strategy and contingency planning and implementation in
partnership with other functional areas to achieve clinical research target.
Delivers competent vendor management at the country level to support the study and may submit
requests for vendor services and support vendor selection. This includes reviewing and approving site
and local vendor invoices as required. As required, manages the local study supply.
Ensures high standards for study monitoring by conducting quality local trial team meetings and
facilitating SM training, when needed (i.e. implementation of study amendment-and changes in study
related processes).
Contributes to patient understanding of protocol and patient safety by preparing country specific
informed consent in accordance with procedural document/templates. This includes reviewing and
managing site specific informed consent forms in accordance with SOPs, other procedural documents
and applicable regulations.
Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting
timelines and documented, as appropriate.
Ensures Inspection readiness by maintaining complete, accurate and timely data and essential
documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to
expectations (metrics) and archiving retention requirements. When issues are identified or trends
across a project are noted from MVR review, will escalate deviation issues to CTM/GTL and FM in
timely manner.
Keeps oneself inspection ready and knowledgeable for current work by complying with relevant
training requirements and developing therapeutic knowledge enough for role and responsibilities.
With focus on quality, will work closely with SM to ensure CAPA is implemented for audits/inspections
or any quality related visits. May conduct accompanied site visits with SM, if delegated by FM.
Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting
deliverables and timelines. This includes forecasting and proactive management of country/local trial
budget. If applicable, may assist in negotiation of trial site contracts and budgets.
Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA
approvals, if applicable.
May contribute as a mentor, champion, or representative of functional area in process initiatives, as
required.
Full utilization by timely and accurate time reporting.
Experience in management and startup of complex Early Phase trials projection with internal matrix
clinical teams and sites, as applicable.
If applicable, region specific deliverables will be specified.
Education and Experience Requirements:
• BA/BS degree.
• Degree in a health or science related field.
• 2 years of local trial management experience.
Specific therapeutic area experience may be required depending on the position.
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. Willingness to travel with occasional
overnight stay away from home according to business needs.
Proficient in speaking and writing the country language and English. Good written and oral
communication skills as appropriate.
#LI-OB1
#LI-remote
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
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.
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
![Man with headphones on looking at a laptop](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/img/5Z6C1pGWd01xPgjadgXIBA/75/5+tips+to+make+a+lasting+impression+in+your+video+interview+2+(1).jpg)
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv
![A picture of Debora Oh](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/img/Oi_Ywfaw1E2c5AjadgdpUA/75/debora-oh-thumbnail.jpg)
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
![women working on a laptop](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/img/n2h6XJiZukZoTQjbEPLPPQ/75/clinical+project+manager.jpg)
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
Who we are
Press play to find out more
![](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/Blob/img/full-width-video.jpg?v=2023.15273-main)
Similar jobs at ICON
Salary
Location
Bucharest
Department
Clinical Trial Management
Location
Bucharest
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a SSU Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-111549
Expiry date
01/01/0001
Author
Dariusz SternlichtAuthor
Dariusz SternlichtSalary
Location
United States
Department
Clinical Trial Management
Location
United States
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Global Clinical Trial Manager, you will play a key role in improving the lives of patients by accelerating the development of our customers ' drugs and devices through innovative solutions. You w
Reference
2024-111550
Expiry date
01/01/0001
Author
Jonathan HolmesAuthor
Jonathan HolmesSalary
Location
United States
Department
Clinical Trial Management
Location
United States
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Global Clinical Trial Manager, you will play a key role in improving the lives of patients by accelerating the development of our customers ' drugs and devices through innovative solutions. You w
Reference
2024-111547
Expiry date
01/01/0001
Author
Jonathan HolmesAuthor
Jonathan HolmesSalary
Location
Belgium
Department
Clinical Trial Management
Location
Belgium
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
2024-110486
Expiry date
01/01/0001
Author
Vanessa VerdicktAuthor
Vanessa VerdicktSalary
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
Overview: 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 t
Reference
2024-111488
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Poland, Warsaw
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Sofia
Warsaw
Johannesburg
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
JR119118
Expiry date
01/01/0001
Author
Fiona CunliffeAuthor
Fiona Cunliffe