Senior Associate Study Management
- United States
- ICON Strategic Solutions
- Clinical Trial Management
TA Business Specialist
- 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:
- Work with the clinical trial management staff to support the execution and monitoring of clinical studies and trial deliverables.
- Participate in study planning and set-up activities including vendor management, project management, and coordination of study and implementation plans.
- Contribute to and support with the preparation, writing and review of study related documents including but not limited to, clinical protocols, consent forms, study guides, monitoring plans, e(CRF)s, subject information sheets, clinical study report, regulatory submissions and publications.
- Quality Check study protocols and ICFs
- Coordinate the activities associated with site start-up and overall trial management
- Assist in identification and evaluation of clinical trial investigators and Phase 1 clinical research units.
- Author monitoring plan, IPD list, IPIM
- Contribute to the study level forecast of IP and support the creation of DSP and JCP
- Provide input into the development of CRFs and SAP
- Contribute to, or coordinate preparation and conduct of site initiations, monitors workshops (as applicable) and investigator meetings (as applicable)
- Assists in preparing and managing Study Budgets and timelines
- Coordinate study level investigational product arrangements and study start-up and management activities.
- Serve as one of the first points of contact within Early Development for study-related issues
- Support vendor relationships
- Perform protocol-related site management activities
- Assists for ensuring all site and study team members are trained on the conduct of the study and they understand the study timelines and deliverables. Coordinate activities as needed between study team members.
What do you need to have?
Knowledge
- Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), FDA regulations and guidelines, and applicable international regulations and guidelines
- Experience in interactions with outside vendors, e.g., CROs and contract labs
- Experience with development of prospective site –selection criteria
- Understanding drug development process and procedures
- Good organization, planning & communication skills
- Project planning experience including oversight of study deliverables, budgets, and timelines
- Ability to use scientific and clinical knowledge to conceptualize study designs
- Experience anticipating and resolving problems
- Experience writing and presenting clearly on scientific and clinical issues
- Experience collaborating and leading cross-functional teams (team/matrix environment)
- Master’s degree or
- BA/BS/BSc or RN & 3 years work experience in a life sciences or medically related field or
- Associate’s degree & 6 years work experience in a life sciences or medically related field
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level
Benefits of Working in ICON:
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.
At 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.
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, 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.
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
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
Similar jobs at ICON
Salary
Location
Romania
Department
Clinical Trial Management
Location
Romania
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Global Study Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114061
Expiry date
01/01/0001
Author
Dariusz SternlichtAuthor
Dariusz SternlichtSalary
Location
Chile
Department
Clinical Trial Management
Location
Chile
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with one of our glo
Reference
2024-113674
Expiry date
01/01/0001
Author
Magda ObregonAuthor
Magda ObregonSalary
Location
United States, Canada
Department
Clinical Trial Management
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Sr Clinical Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114071
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
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 Manager, Fair Market Value, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-113402
Expiry date
01/01/0001
Author
Jonathan HolmesAuthor
Jonathan HolmesSalary
Location
Spain, Madrid
Location
Warsaw
Madrid
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 to join our diverse and dynamic team at ICON in a sponsor dediated position. In this critical role, you will be responsible for overseeing the plannin
Reference
JR121223
Expiry date
01/01/0001
Author
Sophie BinghamAuthor
Sophie BinghamSalary
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 Clinical Trial Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will be responsible for overseeing the planning, execution, and successfu
Reference
JR124159
Expiry date
01/01/0001
Author
Michael HartleyAuthor
Michael Hartley