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http://careers.iconplc.com/job/clinical-data-coordinator-jobid-010082?src=JB-10102Clinical Data Coordinator
- Chennai
- Permanent
- Reference: 010082
Description
161 0 7
DEPARTMENT: Data Management
JOB TITLE: Clinical Data Coordinator I
REPORTS TO: Data Management Project Lead, Data Management Project Manager
JOB TITLE: Clinical Data Coordinator I
REPORTS TO: Data Management Project Lead, Data Management Project Manager
SECTION 1: POSITION SUMMARY
Under supervision of more experienced Data Management Personnel and in accordance with
project specific timelines, to 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 Guidelines, and all laws and regulations.
project specific timelines, to 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 Guidelines, and all laws and regulations.
SECTION 2: JOB FUNCTION / RESPONSIBILITIES
'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.
• '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.
SUPERVISION
• N/A
• N/A
SECTION 3: EXPERIENCE, SKILL, KNOWLEDGE REQUIREMENTS.
• 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
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
SECTION 4: EDUCATION REQUIREMENTS
• Bachelor's degree or local equivalent in a scientific discipline and/or appropriate experience
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.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
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