Clinical Data Manager

2 weeks ago

Sydney, Australia NES FIRCROFT Full time

**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
- Strong clinical systems understanding
- Experience with clinical data registries is preferable

With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Infrastructure, Life Sciences, Mining, Automotive and Chemicals sectors worldwide.With more than 100 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.

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