Bank CV's - Incyte - Clinical Trial Manager-Onc
- United States
- Project Management
- ICON Strategic Solutions
- Remote
About the role
This vacancy has now expired. Please see similar roles below...
As a Senior Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
The Sr Clinical Trial Manager provides input to the overall operational trial(s) implementation, manages trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, functions as the primary liaison for internal stakeholders and vendors leads multidisciplinary departments initiatives, and provides support for process changes to increase efficiency in study executions.
Essential Functions of the Job (Key responsibilities)
- Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality.
- Assist in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
- Manage the evaluation and selection of investigative sites; responsible for feasibility.
- Select, coordinate and monitor activities of vendors.
- Review of monitoring reports and conduct co-monitoring visits, as needed.
- Develop and manage trial(s) timelines, budget and priorities.
- Participate in data review and discrepancy resolution.
- Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress.
- Generate reports to update management on conduct of trial.
- Ensure appropriate clinical trial supply plans are implemented and managed.
- Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.
- Participate in monitoring study safety.
- Develop key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
- Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work.
- Assist with CRA and third party vendor training on protocols and practices.
- Lead the multi-disciplinary trials teams; include the study team meetings.
- Function as the primary contact for trial(s) between Drug Development and other departments.
- Assume responsibility to participate as a member of working groups and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department.
- Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
Qualifications (Minimal acceptable level of education, work experience, and competency):
- BS/BA degree or a relevant degree with strong emphasis on science.
- Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials.
- Able to manage complex and/or large trials.
- Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
- Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
- Demonstrate leadership and problem solving skills.
- Experience in executing a wide range of clinical trial activities (from initiation to clinical study report).
- Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment.
- Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently.
- Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships.
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.
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
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
Career ProgressionContent type
BlogsPublish date
05/30/2023
Summary
Clinical research is the backbone of the life sciences industry. In fact, the established processes used to accurately trial and research medical, surgical and behavioural intervention are ess
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
Mexico, Mexico City
Department
Full Service - Development & Commercialisation Solutions
Location
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Project Management
Job Type
Permanent
Description
JR118149Laboratory Proj. CoordinatorSite: Mexico, Mexico CityOffice BasedAt 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
Reference
JR118149
Expiry date
01/01/0001
Author
Fernanda BezerraAuthor
Fernanda BezerraSalary
Location
Spain, United Kingdom, France
Department
Project Management Roles
Location
France
Spain
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Project 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
2024-109611
Expiry date
01/01/0001
Author
Tanzina GuerniAuthor
Tanzina GuerniSalary
Location
US, Blue Bell (ICON)
Department
Full Service - Development & Commercialisation Solutions
Location
Blue Bell
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Project 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
Reference
JR116651
Expiry date
01/01/0001
Author
Jeff ConnorAuthor
Jeff ConnorSalary
Location
United States
Department
Project Management Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Project 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
2024-109905
Expiry date
01/01/0001
Author
Melissa BennerAuthor
Melissa BennerSalary
Location
US, Portland, OR
Department
Full Service - Development & Commercialisation Solutions
Location
Portland
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Project 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
JR117438
Expiry date
01/01/0001
Author
Frank LampartAuthor
Frank LampartSalary
Location
US, Blue Bell (ICON)
Department
Full Service - Development & Commercialisation Solutions
Location
Blue Bell
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Project 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
Reference
JR116643
Expiry date
01/01/0001
Author
Jeff ConnorAuthor
Jeff Connor