Clinical Data Manager / Sydney

This job has expired or may no longer be taking applications, but other similar jobs are available.

Click here to shortlist this job 1-CLICK Apply With Employer or Register Now

Added:	2022-11-01
Location:	Sydney
Salary:	Competitive salary
Duration:	Permanent
Apjid	3

Clinical Data Manager

Opportunity for an experienced Clinical Data Associate / Data Manager to advance their career
Sydney HQ'd - offering flexible working
Involvement in end to end of the process
Company has rapidly growing Australia wide & global footprint

The role

Responsible for performing assigned data management activities, including database setup, discrepancy management, external data reconciliation, data reviews, interim analyses and database lock.

Support the Senior Clinical Data Manager with all data management activities from study start-up to database lock
Review of Case Report Forms, Edit Checks, Data Management Listings, Query Listings for data cleaning
Lead training on electronic systems for the study including EDC and IRT system
Provide clear verbal or written communication and hands-on support to project team members and to sub-CROs/vendors related to CRF design, data quality and reporting of study results.
Ensure data integrity across projects following applicable regulatory standards, ICH, GCP and SOP.
Monitor data clean-up process, including where performed by sub-CROs/vendors, from study start-up through data archiving.
Manage activities including medical coding, developing data validation checks and managing database snapshots.
Prepare and distribute project status reports to project team and management.
Create and maintain project documentation, including, but not limited to, Data Management Plan, eCRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Design and modify eCRF.
Work with study team and coordinate all data management functions.

You

A positive 'can do' attitude
Degree level qualification in relevant field
2+ years’ experience in clinical data management within a pharmaceutical/biotech/CRO environment
Working knowledge of Clinical Database Applications such as EDC, IWRS and CTMS
Knowledge of clinical research, medical terminology/disease processes and clinical practice
Practical experience applying knowledge of GCP, ICH and other regulatory requirements
Strong clinical systems understanding
Experience with clinical data registries is preferable

How to Apply

Members Login & Apply With Employer or Register Here

70 Brunswick Street
Stockton on Tees
Cleveland
TS18 1DW

About Expats Direct
Expats Direct Services
Become a Member
Find Your Next Job