Study Start up / Contracts associate
- Austria, Bulgaria, Czech Republic, Germany
- ICON Strategic Solutions
- Contracts Administration
- Remote
TA Business Partner
- Full Service Division
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.
As a Study Start up Associate, 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. You will be partnering with one of the worlds premier Biopharmaceutical companies. You will be responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws and Good Clinical Practices.
What you will be doing:
- Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation
- Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in SIP or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status
- Perform timely and accurate task progress communication and data entry of all relevant study start up activities into the appropriate tracking system
- Coordination of all necessary translations required for any start-up documentation
- Attend study team meetings as required
- Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirements
- Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager – Central Services or Designee
You are:
- Bachelor’s Degree preferably in Life Sciences
- Minimum of 2 years’ experience or understanding of clinical study start up requirements and activities
- Experience of Clinical Trial operations and meeting regulatory guidelines
- Proficient project management skills
Ability to work independently and also as a team member and to organize tasks, time and priorities, ability to multi-task
- Excellent oral and written communication skills
- Proficient in German and English
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.
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
Who we are
Similar jobs at ICON
Salary
Location
United States
Department
Clinical Operations Roles
Location
United States
Business Area
ICON Strategic Solutions
Job Categories
Contracts Administration
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
2024-110348
Expiry date
01/01/0001
Author
Jonathan HolmesAuthor
Jonathan HolmesSalary
Location
United States
Department
Clinical Operations Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Contracts Administration
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
2024-110391
Expiry date
01/01/0001
Author
Brandon PupekAuthor
Brandon PupekSalary
Location
South Africa
Department
Clinical Operations Roles
Location
South Africa
Business Area
ICON Strategic Solutions
Job Categories
Contracts Administration
Job Type
Permanent
Description
Title – Clinical Contracts and Budgets Negotiator Location - South Africa – Home basedSponsor dedicated As a Contracts and Budgets Negotiator, you will be joining the world’s largest & most comprehens
Reference
2024-110411
Expiry date
01/01/0001
Author
Shelley BallAuthor
Shelley BallSalary
Location
India
Department
Clinical Operations Roles
Location
India
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Contracts Administration
Job Type
Permanent
Description
The Grants Specialist is responsible for the review; evaluation; accuracy; compliance; and accountability of grants payments in accordance with Clinical Trial Agreement and Client Protocol. The Grants
Reference
2024-109938
Expiry date
01/01/0001
Author
Swathy AnandanAuthor
Swathy AnandanSalary
Location
Germany, Spain, Belgium, Bulgaria
Department
Clinical Operations Roles
Location
Belgium
Bulgaria
Germany
Spain
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Contracts Administration
Job Type
Permanent
Description
As a Contract Analyst you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-110302
Expiry date
01/01/0001
Author
Keri MarshallAuthor
Keri MarshallSalary
Location
United States
Department
Clinical Operations Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Contracts Administration
Job Type
Permanent
Description
As a (job title) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-110294
Expiry date
01/01/0001
Author
Brandon PupekAuthor
Brandon Pupek