Study Start Up Associate I
About the role
This vacancy has now expired. Please see similar roles below...
“At ICON, it's our People that set us
Apart”
Are you passionate about improving the quality of
human life? If so, we invite you to join us in creating a healthier world
tomorrow.
ICON is a global provider of outsourced development
services to the pharmaceutical, biotechnology and medical device industries. We
specialize in the strategic development, management and analysis of programs
that support Clinical Development - from compound selection to Phase I-IV
clinical studies.
We started as a team of 5 members in 1990 &
today we are ranking at top 4 worldwide based on revenue of 2015. Currently we
have 12200+ employees across the globe. ICON is a $1.575bn company having
its presence across 89 offices in 37 countries.
Job Title
: Study startup associate I
Reporting
to
: Manager
Type of Employment : Full
Time
Location
: Trivandrum, office based
Summary:
Responsible for the review and approval of site level critical
documents which are part of the Critical Document Package (CDP) for
Investigational Product (IP) release in accordance with ICH/GCP guidelines and
all applicable regulations, laws, ethical standards, other guidelines and
sponsor requirements.
Key
Responsibilities & Duties:
·
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.
·
Perform high quality CDP reviews according to
the process defined in SOP SST004 titled “Critical Documents Collection,
Critical Document Package (CDP) Approval and IP Release.
·
Provide SSU Lead/designee with CDP
Requirement Sheet to discuss with the Sponsor.
·
Update CDP Requirement Sheet during the
start-up phase of studies in consultation with the SSU Lead/designee.
·
Customize final Critical Document Package/IP
Release Checklist and Global CDP Review Worksheet including any Sponsor,
Country and Study Specific requirements.
·
Complete CDP reviews within defined and agreed
timelines of receipt by the CDP Review Team/designee.
·
Complete review of CDP documents alongside
the supporting Critical Document Package/IP release Checklist to confirm all
the CDP documents are complete, consistent, current and in accordance with ICH/GCP
and all applicable regulations, laws, and other guidelines and ethical standards.
·
Return to CDP Submitter any documents
identified as incomplete, not current or inconsistent. x Sign and date the
“Approved By” section of the Critical Document Package/IP Release Checklist to
confirm approval of CDPs which are complete, consistent, current and in
accordance with ICH/GCP and all applicable regulations, laws and other guidelines
and ethical standards. X
·
Enter details of CDP review into the CDP
Approval Tracker at completion of each review.
·
Upload approved CDPs to agreed electronic
filing system.
Experience
required
2 to 3 years pf experience
in ICH/GCP
Deep knowledge in Documentation
Academic or Trade qualifications:
Any life science
Benefit Working
with ICON:
Other than working with a great team of smart
and energetic people, we also offer a very competitive salary and benefits
package that includes an excellent pension scheme, private health care, and
life assurance and staff recognition schemes. This varies from country to
country so a dedicated recruiter will discuss this with you at interview
stage.
PROCESS
Technical and competency selection:
When you spot an opportunity you’re
interested in and submit an application, one of our Talent Acquisition
Specialists will contact you to evaluate your suitability for this position, as
well as for other openings within the business.
The evaluation will look at your technical
skills and your competencies – for example, delivering excellence.
Interview
After this, we’ll let you know if we’ll be
progressing with your application. If you have been successful at this stage,
we will talk you through a telephone interview. This will then be followed by
an interview with our Hiring Manager, either face to face or by tele-conference.
Offer
If you’re successful, we will notify you with
details of the offer, talk you through our culture and values, answer any
questions you may have – and above all, welcome you to the ICON team.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
Teaser label
IndustryContent type
BlogsPublish date
11/29/2024
Summary
Understanding Clinical Trials Phases: A Therapeutic Area Perspective Clinical trials represent the cornerstone of modern drug development, with each phase serving a distinct and crucial purpose in
Teaser label
IndustryContent type
BlogsPublish date
11/19/2024
Summary
Decoding Clinical Research Abbreviations: Essential Terms Explained Clinical research professionals use hundreds of abbreviations every day. Simple letters like AE mean Adverse Event, while longer
Teaser label
Our PeopleContent type
BlogsPublish date
11/13/2024
Summary
How to Become a Clinical Research Associate: A Step-by-Step Guide The clinical research industry is projected to reach $52.0 billion by 2026, growing at an impressive rate of 5.6% annually. This
Similar jobs at ICON
Salary
Location
Germany
Department
Clinical Monitoring
Location
Germany
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a CRA II in Germany you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.You will be partnering with one of the worlds pre
Reference
2024-114991
Expiry date
01/01/0001
Author
Sarah CameronAuthor
Sarah CameronSalary
Location
Mumbai
Department
Study Start Up
Location
Mumbai
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
The Study Startup Associate is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study time
Reference
2024-114861
Expiry date
01/01/0001
Author
Kalpana KulasekaranAuthor
Kalpana KulasekaranSalary
Location
US, New York, NY, Farmingdale
Department
Full Service - Development & Commercialisation Solutions
Location
Farmingdale
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Supplies
Job Type
Permanent
Description
Location: Farmingdale, NYWe are currently seeking a Sample Management Coordinator I to join our diverse and dynamic team. As a Sample Management Coordinator at ICON, you will play a pivotal role in co
Reference
JR126279
Expiry date
01/01/0001
Author
Tina GeerAuthor
Tina GeerSalary
Location
India, Bangalore
Department
Full Service - Corporate Support
Location
Bangalore
Bengaluru
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Proposals
Job Type
Permanent
Description
The role:This is an exciting opportunity to join the Client Management side of our Contracts team within the Clinical Research Industry. Do you have an interest in negotiation, Contracting and budgeti
Reference
JR126129
Expiry date
01/01/0001
Author
Puja JaiswalAuthor
Puja JaiswalSalary
Location
India, Chennai
Location
Chennai
Trivandrum
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug Safety
Job Type
Permanent
Description
Job Description SummaryThis role is for an STL (Safety Technology Lead) within the PVSS / SRG group.The primary function is to serve as a global contact and interface for the PV business for ICON Safe
Reference
JR124027
Expiry date
01/01/0001
Author
Archana BakkiyarajanAuthor
Archana BakkiyarajanSalary
Location
Poland, Warsaw
Department
Full Service - Development & Commercialisation Solutions
Location
Warsaw
Bucharest
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Project/ Program Management
Job Type
Permanent
Description
The Manager’s primary responsibilities are managing business growth and development of staf in their respective department. This involves the oversight of the functional team’s portfolio including res
Reference
JR125069
Expiry date
01/01/0001
Author
Lourdes Roy PratsAuthor
Lourdes Roy Prats