CDC II

Job Title: Clinical Data Coordinator II

Division: ICON Early Phase

Job Location: Chennai/Trivandrum

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. 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 law and regulations.

Overview of the Role

• Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.
• Record all billable and non-billable time in the appropriate timesheet management s stem (e.g. Planview™).
• Performing Rave DB testing and Edit Check Testing.
• Review CRF or eCRF data for completeness, accuracy, and consistency via computerize 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.
• 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 a e met (for example, filing and archiving of study documentation , dispatching of queries to investigation or sites for resolution, etc.).
• As required, communicate effectively with the Project team, Study Lead, Project Lead and Project Manager.

Role Requirements

• A minimum of 3-5 years of relevant clinical research industry experience.
• Experience or Knowledge on Data Validation Plan/Data Validation Specification and eCRF Completion guidelines would be an added advantage.
• Excellent written and oral communication skills.
• Excellent accuracy and attentiveness to detail.
• Capability to work within a team environment.
• Excellent interpersonal skills.
• Knowledge of database technologies and processes.
• Knowledge of regulatory guidelines in relation to data quality and clinical trials conduct.

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. 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.