Study Start Up Associate II
About the role
This vacancy has now expired. Please see similar roles below...
At ICON, it's our people that set us apart.
As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?
As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.
Summary
Provide support towards US SSU Maintenance Activities. Including but not limited to;
# Coordinating IRB Submissions & follow up for approvals
# CTMS and Tracker Updates
# Timely TMF QC and uploads
The Role
Prepare, coordinate review, submit and QC submissions to ethics, regulatory and other authorities to obtain clinical trial authorizations and approvals.
Collect critical documents for maintenance activities.
Assist with finalization/approval of country and site Specific SIS/ ICFs in collaboration to the LIC team.
Perform site contract negotiation including of budget and contract amendments, as required.
Upload final documents to agreed electronic filing system (Activate, TMF, etc.) and perform updates as required to systems e.g. CTMS.
Lead activities/ tasks and complete the deliverables within timelines, as needed
Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
Liaise with internal ICON and external (e.g. site personnel, IRBs etc.) stakeholders to deliver maintenance support activities during the clinical trial
What you need
Bachelor's degree in a life science/health related sciences, or equivalent
Minimum of 4 to 5 yrs of experience in IRB submissions and approvals, Ethics committee submissions for US & EU
Excellent communication skills
Why join us
Ongoing development is vital to us, and as a Medical Writer, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.
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
Inclusion & BelongingContent type
BlogsPublish date
04/29/2024
Summary
Cultural Fit in the Workplace Finding the perfect cultural fit is crucial when searching for a new employer. It goes beyond just the job description and salary package. Cultural fit refers to how
Teaser label
IndustryContent type
BlogsPublish date
04/29/2024
Summary
Precision medicine is a groundbreaking approach that aims to revolutionise healthcare by tailoring medical treatments to individual patients. Unlike traditional medicine, which adopts a one-size-fi
Teaser label
Our PeopleContent type
BlogsPublish date
04/29/2024
Summary
Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o
Who we are
Similar jobs at ICON
Salary
Location
Mexico City
Department
Study Start Up
Location
Mexico City
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
The Study Start Up. Assocate II, collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs,
Reference
2024-110039
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Mexico
Department
Clinical Operations Roles
Location
Mexico
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
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
2024-110036
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Mexico
Department
Clinical Operations Roles
Location
Mexico
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
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
2024-109897
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Mexico, Mexico City
Department
Full Service - Commercial Solutions
Location
Mexico City
Sofia
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Proposals
Job Type
Permanent
Description
Business Intelligence AnalystLocation: Hybrid Mexico City - (Insurgentes Sur) At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and h
Reference
JR117427
Expiry date
01/01/0001
Author
Ana LuciaAuthor
Ana LuciaSalary
Location
Mexico City
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Mexico City
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Drug Safety
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
2024-110055
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Mexico, Mexico City
Department
Full Service - Medical Affairs & Pharmacovigilance
Location
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Project/ Program 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
JR116055
Expiry date
01/01/0001
Author
Daniela GuerreroAuthor
Daniela Guerrero