Senior CDC

“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. Planview^TM).

·                   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

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 you’re 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, we’ll let you know if we’ll 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 you’re 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.