Senior Clinical Trial Manager (East Coast) Remote
- United States
- ICON Strategic Solutions
- Clinical Trial Management
- Remote
About the role
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.
The clinical study manager is responsible for all operational aspects of the assigned clinical studies from initiation till closure of the studies. The successful candidate will have clinical study operational experience in phase I, II and III drug development phases and is an operational expert in the clinical study activities from start-up, execution until closure and its underlying activities. The CSM will be the “operational clinical study voice” for the assigned studies, both internally and externally, he or she is owning the timelines of a clinical study project and is accountable to keep the study on track. The successful candidate will excel in establishing good and effective internal and external working relationships.
What you will be doing:
The CSM is responsible for all clinical operational aspects for the assigned global clinical studies from preparation until closure. The study responsibilities include:
- Responsible for leading and guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical studies based upon metrics and plan
- Leading CRO contracts negotiations together with the argenx vendor manager
- Providing input into and/or developing study related materials such as Clinical Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, study drug order forms etc.
- Overseeing and tracking patient recruitment and pro-actively identifies ways to prevent recruitment delays
- Ensuring that study Trial Master File is maintained and up to date
- Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations
- Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns
- Facilitating timely availability of investigational product supply on site and ensuring that clinical site accountability records on site are maintained
- Ensuring timely collection of documentation for adverse event safety monitoring and collaborating in submission of MedWatch reports to FDA, EMEA and other applicable regulatory authorities
- Ensuring timely SAE reporting to the responsible IRB and Competent Authority agencies according to the applicable (local) legislation.
- Establishing and maintaining good relation with clinical site and study personnel
- Co-monitoring CROs personnel upon predefined plan
- Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to Project Manager, Head of Clinical Operations or Senior Management, if needed
- Leading and guiding the internal clinical study team and chairing study team meetings
- Communicating in a transparent, clear way and motivating team members to work towards achieving clinical study goals
- Preparing of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan
- Ensuring that the assigned studies are executed according to the argenx quality standards
- Responsible for risk management of the assigned studies: performing (pre-)study risk assessment and ensuring that mitigation steps for potential risks are taken
- Responsible and contact person during inspections/audits for the assigned studies together with the Quality Assurance representative
You are:
The CSM will also participate in activities other than study-related which include but are not limited to:
- Co-writing/maintaining SOPs within the Clinical Operations department
- Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study
- Experience with tools and systems for managing clinical studies (MS project, study progress and metric systems, eCRF databases)
- Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
- Minimum of 5 years of experience in Clinical Operations and managing CROs and vendors globally
- Biotech experience is a plus
- Auto-immune and/or oncology clinical study background is a plus
- Providing input to the clinical development strategy/plan
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
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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
07/20/2023
Summary
Unlocking your Potential: The Benefits of ICON’s EPIC Internship Program Internship programs have become a vital stepping stone for students and young professionals seeking to gain practic
Teaser label
Our PeopleContent type
BlogsPublish date
02/28/2023
Summary
John Bailey, one of ICON's Veteran Leadership Transition Program Alumni shares his path from serving in the armed forces to joining the clinical research industry. ICON's Veteran Leadership Transit
by
John Bailey
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