Clinical Data Coordinator @ ICON
Description
This
is an exciting opportunity to work within a fast paced, busy environment for a
leading global provider of outsourced development services to the
pharmaceutical, biotechnology and medical device industries. A Clinical Data
Coordinator under the supervision of more experienced Data Management Personnel
and in accordance with project specific timelines perform basic data management
activities to ensure the generation of accurate, complete, and consistent
clinical databases. 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
Overview
of the role
- Recognize, exemplify and adhere
to ICON's values which centers 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
- Travel (approximately 0%)
domestic and/or international
- Read, ensure understanding and
adhere to all assigned ICON SOPs and working procedures
- Ensure all work performed is of
high quality, compliant with Good Clinical Practice, ICH Guidelines and
all applicable laws and regulations
- Complete all assigned training
and courses 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.
Planview™)
- Review CRF/eCRF data for
completeness, accuracy, and consistency via computerized edits and manual
data checks
- 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
- Participate in User Acceptance
Testing under supervision of the Study Lead
- Perform Quality Review of
clinical data
- 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
Role
Requirements
- Bachelor's degree or local
equivalent in a scientific discipline and/or appropriate experience
- To perform this job
successfully, an individual must be able to perform each essential duty
satisfactorily. The requirements listed below are representative of the
knowledge, skill, and/or ability required. Reasonable accommodations may
be made to enable individuals with disabilities to perform the essential
functions.
- Prior Data Management
experience preferred
- Strong written and oral
communication skills
- Ability to work within a team
environment
- Excellent interpersonal skills
- General computer literacy.
Knowledge of database technologies and processes is a plus
- Knowledge of medical
terminology is a plus
Benefits
of Working in 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, life assurance and staff recognition
schemes. This varies from country to country so a dedicated recruiter
will discuss this with you at interview stage.
We
care about our people as they are the key to our success. We provide an open
and friendly work environment where we empower people and provide them with
opportunities to develop their long term career.
What’s
Next
Following
your application you will be contacted by one of our dedicated recruiters and
if successful we will be able to provide you with more details about this
opportunity.
0 comments:
Post a Comment