Job Title: Clinical Data Coordinator III - EDINBURGH, SCOTLAND
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Vacancy details
Vacancy description:
Job Code:
DATAED
Job Title:
Clinical Data Coordinator III - EDINBURGH, SCOTLAND
Job Category:
IT & Data Management
Contract:
Permanent
Discipline:
Clinical Data Coordinator
Country:
United Kingdom
Location:
Midlothian
Min experience:
3 years
Annual salary:
Negotiable
Apply by:
25 Jul 2008
* APPLICANTS LIVING IN SCOTLAND ONLY PLEASE**
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 teams have successfully conducted over 1,900 development projects and over 2,300 consultancy engagements across all major therapeutic areas. ICON currently has over 4,800 employees, operating from 53 locations in 31 countries
*APPLICANTS LIVING IN SCOTLAND ONLY PLEASE*
DEPARTMENT: Data Management
JOB TITLE: Clinical Data Coordinator III
REPORTS TO: Appropriate Data Management manager
A. PURPOSE OF THE JOB:
• 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.
B. JOB FUNCTIONS/RESPONSIBILITIES:
• Review Case Report Form (CRF) data for completeness, accuracy, and consistency.
• Identify and resolve data discrepancies. As appropriate, apply Level I corrections to CRFs.
• Generate and resolve (as appropriate) data queries.
• Update/correct/review data in the clinical databases based on resolved data queries.
• Assist with the testing of data entry screens and the preparation of the relevant testing documentation. Assist with the validation of edit check programs.
• Update tracking systems as necessary (for example, tracking of CRF review activities and queries from generation through to resolution, etc.)
• Assist the DBA with the design of the clinical study database in accordance with relevant procedures.
• Create dummy data for testing data entry screens and edit checks. Validate data entry screens and edit check programs.
• Perform additional data management activities as required to provide high quality data for the purposes of analysis and/or regulatory submissions (for example, data listings review, manual audits, AE collapsing and AE splitting, AE and SAE reconciliation, external data reconciliation, medical dictionary coding).
• Generate appropriate and timely status reports for internal management.
• Develop, review, and maintain relevant SSPs. (for example: edit check specifications, data handling conventions, laboratory data check specifications, SAE reconciliation, medical dictionary coding, quality review) Control the distribution of SSPs.
• Create and maintain study binders in accordance with SOPs.
• Perform other project activities as required in order to ensure that study timelines are met (for example, data entry tasks, filing and archiving of study documentation, dispatching of queries to investigator sites for resolution, etc.).
• As appropriate interact effectively with the Manager, Data Entry in regards to data management matters (for example, CRF flow, quality of data entry).
• As required, communicate effectively with the project team as well as with other ICON personnel, and/or investigative site personnel. Keep the project team and other relevant contacts informed of project status in relation to both quality and timelines.
• Train and guide less experienced Clinical Data Coordinators in data management requirements and activities, including adherence to GCPs, ICON SOPs, WPs, SSPs, ICH Guidelines and applicable laws and regulations.
C. QUALIFICATIONS/EXPERIENCE REQUIRED:
• Bachelor’s degree or the equivalent in a scientific discipline and/or appropriate experience.
• Two to five years of data management experience.
• Knowledge of database technologies and processes, including experience-performing data edits using clinical data management software.
• Assist in training in Data Management activities with a working knowledge of regulatory guidelines particularly in relation to data quality and clinical trials conduct.
• Excellent accuracy and attentiveness to detail.
• Excellent written and oral communication skills. Excellent interpersonal skills.
• Ability to work within a team environment. Ability to handle stressful work situations and deadlines.
ICON is an equal opportunities employer and offers all candidates competitive salary and benefits packages.
You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
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