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
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: CDC I - 006286
Job 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
- 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
- Experience of 3-7 years in Clinical Data Management.
- 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.
Additional Information:
Location: Trivandrum, Chennai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 11th Oct, 2013
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