Senior CDC
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 : Sr Clinical Data Coordinator
Reporting to : Manager
Type of Employment : Full Time
Location : Chennai / Trivandrum
No of yrs. of exp : 6+ relevant yrs. Of experience
Summary:
In accordance with project specific timelines, to perform data management activities to ensure the generation of accurate, complete, and consistent clinical databases.
To assist with the training of less experienced Clinical Data Coordinators.
To fulfill his / her job responsibilities in accordance with Good Clinical Practices (GCPs), ICON Standard Operating Procedures (SOPs), Working Procedures (WPs),Study Specific Procedures (SSPs), International Committee on Harmonization (ICH) Guidelines, and all applicable laws and regulations.
Key Responsibilities & Duties:
Complete all assigned trainings (including the Study Lead Development program) and co rses in the ICON Training Management system (iLearn); ensuring that mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies.
Record all billable and non-billable time in the appropriate timesheet management system (e.g. PlanviewTM).
Review CRF / eCRF data for completeness, accuracy, and consistency via computerized edits and manual data checks.
Perform external data reconciliation.
Perform Serious Adverse Event reconciliation.
Generate and close/resolve (as appropriate) data queries.
Freeze and/or lock eCRFs (as appropriate) within the Electronic Data Capture System.
Create and maintain study files and other appropriate study documentation.
Perform User Acceptance Testing and collaboratively work with CDMS personnel to see issues found through re-testing and resolution.
Assist Data Management Study Lead in development of eCRF, Data Validation Specifications, and Study Specific Procedures.
Train and guide less experienced CDCs in data management requirements and activities.
Perform other project activities as required in order to ensure that study timelines are met (for example, filing and archiving of study documentation, dispatching of queries to investigator sites for resolution, etc.).
As required, communicate effectively with the Project team, Study Lead, Project Lead and Project Manager.
Experience required
A minimum of 6 year relevant clinical research industry experience.
Prior relevant clinical research industry experience.
Excellent written and oral communication skills.
Excellent accuracy and attentiveness to detail.
Capability to work within a team environment.
Academic or Trade qualifications: Any graduate
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 youre 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, well let you know if well 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 youre 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.
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
Netherlands, Groningen GRQM (PRA)
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Groningen
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Facilities & Administratives Services
Clinic
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
JR118367
Expiry date
01/01/0001
Author
Stephanie Broize-ArrieuAuthor
Stephanie Broize-ArrieuSalary
Location
Poland
Department
Clinical Operations Roles
Location
Poland
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
2024-110172
Expiry date
01/01/0001
Salary
Location
Reading
Department
Clinical Monitoring
Location
Reading
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
We are recruiting experienced UK-based Senior CRAs who are looking for a developmental role - with a strong ability to build relationships at site (involved in problem solving and data review). You w
Reference
2024-110167
Expiry date
01/01/0001
Salary
Location
India
Department
Clinical Monitoring
Location
India
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
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
2024-110031
Expiry date
01/01/0001
Author
Kalpana KulasekaranAuthor
Kalpana KulasekaranSalary
Location
India
Department
Clinical Monitoring
Location
India
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
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
2024-110030
Expiry date
01/01/0001
Author
Kalpana KulasekaranAuthor
Kalpana KulasekaranSalary
Location
India, Chennai
Location
Bangalore
Chennai
Trivandrum
Bengaluru
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Programming
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
JR117921
Expiry date
01/01/0001
Author
Caroline SweetyAuthor
Caroline Sweety