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Salarydatamanager_1708060255 Posted: 16/02/2024
- Australia
- Permanent
A specialised Clinical Data consultancy is seeking a Senior Data Manager to help lead and strengthen the project portfolio across Australia. This position will be responsible for managing the full end-to-end data management initiatives across multiple global clinical trials - being the point of contact for sponsors as well as internal teams and so strong communication skills is essential.
This is an exciting opportunity for anyone with global experience (Europe, South Africa, or USA) who is comfortable managing this type of project scope.
You will be joining a small team of experienced data experts and clinical staff, as well as working alongside senior management and so presents strong opportunity to improve processes and strategies.
They partner with multiple biotech/pharma sponsors and so offer a variety of complex project work.
Suitable for an experienced Clinical Data Manager with a strong understanding of clinical trials.
Key Responsibilities:
The Senior/Principal Clinical Data Manager will be responsible for managing all aspects of clinical trial data from study start-up through database lock. This includes developing and implementing data management plans, designing case report forms, overseeing data entry and validation, and generating study-specific data reports. The ideal candidate will be a detail-oriented, self-starter who can work independently and collaboratively in a fast-paced, small company environment.
- Develop and implement data management plans for clinical trials
- Design case report forms (CRFs) and review/edit CRFs created by CROs or study teams
- Manage electronic data capture (EDC) systems and oversee data entry and validation
- Ensure data quality and accuracy by conducting data review and query resolution
- Create and review data reports for clinical study team and regulatory submissions
- Perform database lock and archiving activities in accordance with SOPs and regulatory requirements
- Contribute to the development and improvement of data management processes and procedures
- Collaborate with cross-functional study teams to ensure timely and accurate data collection and reporting
- Bachelor's degree in a relevant scientific discipline (e.g., biology, chemistry, statistics) or equivalent experience
- Minimum of 2 years of experience in Clinical Data management, preferably in a CRO environment
- Knowledge of ICH/GCP guidelines and FDA/EMA regulations
- Experience with EDC systems and CRF design
Location: Melbourne (hybrid offered)
Do not hesitate to apply if you are interested. Please send your CV to Keeley Munday at 02 8310 5854 or apply direct to this link for a further confidential discussion.
