Study Start Up Associate - German speaking
- Sofia, Prague, Budapest, Bratislava
- Study Start Up
- ICON Full Service & Corporate Support
- Hybrid: Office/Remote
Senior Talent Acquisition Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please see similar roles below...
Study Start Up Associate II
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 It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Study Start Up Associate II
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.
The Role
• To review and negotiate clinical site investigator contracts and budgets.
• Stay connected with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents
• Prepare and coordinate preparation of contractual documents and correspondence
• Facilitate the indemnification process between the study sponsor and the site.
• Function as the internal consultant on study budgets (investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the SSU department, and act as consultant on the Investigator Contract and Budget development process from origination through execution).
Prepare, review and negotiate Master Service Agreements with sites.
o Competent Authority (CA), Ethics Committee (EC) and Institutional Review Board (IRB) Submissions:
. Proficiently collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
. Effective interaction with Ethics Committees, Institutional Review Boards and Country Regulatory Agencies (Competent Authorities) to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct (start up and maintenance as assigned).
. Forecast submission/approval timelines and ensure they are achieved; provide risk and contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified.
o Preparation, Submission, Review and Approval of Critical Document Package (CDP):
. Proficient essential document collection and review, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable country requirements and ICH/GCP guidelines.
. Preparation and submission of site level critical documents which are part of the Critical Document Package (CDP) to the Central CDP Review Team (CDPRT) and Sponsor.
. Review and approval of Critical Document Package (CDP).
. Investigational Product (IP) release in accordance with regulatory and Sponsor requirements.
. Accurately forecast CDP Approval timelines and ensure they are reflected accurately in ICON’s systems, proactively follow through for achievement to plan; provide risk assessment and contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified.
. Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.
What you need
• A bachelor’s degree in Paralegal Studies, Juris Doctor (law) degree, or related experience is preferred
• SSU experience is desirable but not required.
• Experience in a clinical research environment with specific experience in study contracts review and budget negotiation or in related field such as where contract or legal document review is a primary part of you role.
• Fluency in German and English required
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON 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 through the form below.
#LI-remote #LI-AC1
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
Career ProgressionContent type
BlogsPublish date
12/21/2022
Summary
Salary expectations used to be something discussed after an interview process but now it’s something most recruiters typically ask within the first conversation. This is to ascertain if the remune
by
Jamie Kempski
Teaser label
Inside ICONContent type
BlogsPublish date
11/24/2022
Summary
Life sciences are undeniably an exciting area to start and pursue a career in. In fact, the global life sciences space is predicted to be worth a massive $2 trillion in gross value by 2023. Contra
Similar jobs at ICON
Salary
Location
Thailand, Bangkok
Location
Bangkok
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
We are currently seeking a Senior Study Start Up Associate to join our diverse and dynamic team. As a Senior Study Start Up Associate at ICON, you will be working within a large-scale, fast-paced envi
Reference
JR124609
Expiry date
01/01/0001
Author
Jennifer KimAuthor
Jennifer KimSalary
Location
Chile, Santiago
Location
Santiago
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
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
JR122841
Expiry date
01/01/0001
Author
Diego ToniniAuthor
Diego ToniniSalary
Location
India, Bangalore
Department
Study Start Up
Location
Bangalore
Bengaluru
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Feasibility
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
JR123508
Expiry date
01/01/0001
Salary
Location
US, Blue Bell (ICON)
Location
Blue Bell
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Feasibility
Patient Recruitment
Job Type
Temporary Employee
Description
We are currently seeking a Patient Recruitment Assistant to join our diverse and dynamic team. As a Patient Recruitment Assistant, you will play a crucial role in identifying potential study participa
Reference
JR119460
Expiry date
01/01/0001
Author
Mitzi OvertonAuthor
Mitzi OvertonSalary
Location
France, Paris
Location
Paris
Lisbon
Bucharest
Barcelona
Madrid
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
Study Start Up Associate IIAt 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
Reference
JR124478
Expiry date
01/01/0001
Author
Jaziara HancoxAuthor
Jaziara HancoxSalary
Location
Taipei
Department
Study Start Up
Location
Taipei
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
SSU Clinical Research Associate (CRA) - FSP Model, Global Pharma (10 months contractor)Location: Taipei, Taiwan As a SSU Clinical Research Associate (SSU CRA) you will be joining the world’s largest &
Reference
2024-113793
Expiry date
01/01/0001
Author
Sandy TangAuthor
Sandy Tang