Local Trial Manager
- Czech Republic
- ICON Strategic Solutions
- Clinical Trial Management
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
As a Clinical Trial Manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
- Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out at a country level in accordance with ICH-GCP and other applicable local regulation
- Maintains the quality and scientific integrity of clinical trials at a country leve
- Collaborates with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial deliverables within the countr
- Maintains expert country, site and protocol knowledge to support sites with questions as well as build strong site relationship
- Partners with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery.
- Accountable for study deliverables and drives key decisions within set country.
·Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST). ·Supports country-level operational planning and accountable for site selection within assigned country/-ies. ·Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents. ·Supports and contributes to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda driven, present at meetings. ·Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers [GCM], Program Managers, CST or TMT, Development Operations Manager [DOM] etc) with oversight as required and ensures updates to relevant systems. ·Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies. ·Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training. ·Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning. ·Engages with local cluster team and local functions from a study perspective (e.g., Local Medical Affairs team, DOM). ·Provides country level input into the Country Operational Plan (COP) and partner with the DFM through feasibility and with the GCMs to ensure local delivery of the study. ·Responsible for approval of Baseline and Revised Enrolment Plans (Country Level). ·Contributes to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates) process. ·Monitors the execution of the clinical study against timelines, deliverables, and budget for that country. ·Translates global start up requirements into local country targets ·Monitors country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment and retention strategic solutions. ·Monitors and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate. ·Monitors and reviews country and study trends. ·Reviews Monitoring Visit Reports. ·Identifies and facilitates resolution of cross-functional study-specific issues. ·Provides updates regarding the study budget and obtains approval for budget deviations for clinical sites (outside of range). ·Escalates any issues related to delivery, timelines, or budget to GCMs (or TMT le ad if appropriate). ·Escalates CRA performance issues to applicable Clinical Trial Oversight Manager. ·Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships. ·Executes regulatory agency inspection readiness activities (e.g., TMF review, story board generation). ·Supports internal audit and inspection activities and contributes to CAPAs, including leading resolution of issues when appropriate e.g., vendor management. ·Participates in cross-functional task forces/process improvement groups ·Assigns and oversees deliverables of study support staff e.g., Study Management Associate, ASM/SASM (Snr./Assc. Study management) and continually reviews country level risk mitigation to ensure study delivers to plan. ·Collaborates with local teams to ensure country level study delivery is aligned with global expectations. ·Coordinates of the site contracting, budgeting, insurance and payment process by overseeing local support roles (e.g., CTA, SCBA, Legal). ·Identifies risk, implementing risk mitigation strategies, and resolving issues at a country/site level, as well as informing the CST / TMT, LST and local teams of risks associated with delivery in a proactive, timely and solution orientated manner. Contribute to study-level risk assessments. ·Leads and continually reviews country level risk mitigation activities to ensure study delivery to plan. ·Maintains relevant therapeutic knowledge. ·Triages / tailors communication from study / local team to sites to ensure efficient and effective communication flow. |
• Minimum 2-3 years’ experience of leading local/regional or global teams ·Local Czech Republic knowledge / expertise of regulatory environment, study start up process and associated timelines etc. ·Clinical trial processes and operations and trial management experience ·Extensive knowledge of ICH/GCP regulations and guidelines ·Project and Program management experience including oversight of study deliverable, budgets and timelines ·Time, cost and quality metrics, key performance indicators (KPIs) ·Relevant Therapeutic knowledge is preferred
Key Competencies: ·Matrix team leadership ·Project Management skillset ·Critical thinking and horizon scanning ·Problem solving ·Decision making ·Delegation skills ·Relationship Management and influencing skills
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. #LI-DD1 #LI-remote |
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
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
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
Similar jobs at ICON
Salary
Location
Regional United States (PRA)
Department
Clinical Trial Management
Location
Multiple US Locations
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
We are currently seeking a CTM II to join our diverse and dynamic Biotech team with a therapeutic alignment of Gen Med. As the CTM II, you will hold a crucial role in ensuring the successful delivery
Reference
JR121420
Expiry date
01/01/0001
Author
Tina GeerAuthor
Tina GeerSalary
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
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
2024-112587
Expiry date
01/01/0001
Author
Jonathan HolmesAuthor
Jonathan HolmesSalary
Location
Mexico, Mexico City
Department
Clinical Trial Management
Location
Brazil
Chile
Colombia
Peru
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
We are currently seeking a Clinical Trial Manager II to join our diverse and dynamic Biotech team with a therapeutic alignment of Gen Med including MASH/NASH, Rare Disease studies, etc responsible for
Reference
JR122763
Expiry date
01/01/0001
Author
Tina GeerAuthor
Tina GeerSalary
Location
Mexico, Mexico City
Department
Clinical Trial Management
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
We are currently seeking a Senior Centralized Clinical Trial Manager to join our diverse and dynamic team. As a Senior Centralized Clinical Trial Manager at ICON, you will play a pivotal role in overs
Reference
JR120126
Expiry date
01/01/0001
Author
Michael HartleyAuthor
Michael HartleySalary
Location
Mexico, Mexico City
Department
Clinical Trial Management
Location
Brazil
Chile
Colombia
Peru
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
We are currently seeking a Senior Clinical Trial Manager to join our diverse and dynamic team. As the Senior Clinical Trial Manager, you will hold a crucial role in ensuring the successful delivery of
Reference
JR115319
Expiry date
01/01/0001
Author
Jasmine GarciaAuthor
Jasmine GarciaSalary
Location
United Kingdom, Spain, Italy, Germany
Department
Clinical Trial Management
Location
Germany
Italy
Spain
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
Ttitle - Clinical Study Operations Manager - must have experience in managing studies in the NetherlandsLocation - can be based in the UK, Spain, Italy or GermanySponsor dedicated ICON plc is a world-
Reference
2024-113458
Expiry date
01/01/0001
Author
Amani YousefAuthor
Amani Yousef