- Datapharm Australia is a leading local contract research organisation (CRO) providing clinical trial management and data analysis for local and global pharma and biotech companies.
- This is an opportunity to join a busy Data Management team using the latest EDC technologies and be trained and mentored by a Senior Data Manager.
- The Data Manager role can be started at Entry Level through to Senior dependent on your experience.
- There are opportunities within Datapharm to learn new skills and also to grow by untapping your hidden talents to try new roles and responsibilities.
- We will consider entry-level positions, hybrid roles for those with programming skills, short-term contracts and longer term career opportunities.
Data Manager Role:
- Design CRFs and eCRF databases
- Assist in development of data management study specific documentation, Data Validation Plan (DVP), Data Management Plan (DMP), CRF Completion Guidelines
- Perform internal validation testing (IVT) for EDC database
- Support clinical data management processes for clinical studies from set up to database lock
- Actively provide data cleaning activities including tracking, conducting cross-functional data checks, schedule data review, reconciliation serious adverse events (SAEs), identify data quality issues and follow-up all queries to resolution
- Assess and track protocol deviations
- QC data listings ready for final report
- Organise QC checks on data prior to database lock
- Prepare meeting agendas for team and write minutes as required
- Degree in life sciences (Pharmacology/ Medicine/ Pharmacy/ Nursing/ Medical Science) or Health Information Systems
Skillset and Desirable Attributes:
- Experience working in MS Office Suite (Excel, Word, Access, PowerPoint), Adobe, databases and various browsers
- Enthusiasm and experience working as part of a busy, interactive and interdependent team
- Ability to anticipate, trouble-shoot and resolve various types of problems
- Good self-management skills and the ability to meet deadlines and manage multiple tasks
- Self-motivated, tenacious and achievement orientated
- Excellent attention to detail
- Demonstrated ability to communicate clearly and accurately in both written and spoken English with clients and site staff
- Desirable: Some knowledge of clinical research, medical terminology/disease processes, use of CRFs, clinical databases and ICH GCP
- Desirable: Any post-graduate qualification in Data Science, Programming or Statistics
Datapharm Australia Pty Ltd is a local contract research organisation, founded in 1987. Datapharm is a one-stop shop supporting the pharmaceutical and biotechnology companies conducting clinical research by setting up and monitoring clinical trials, collecting the data using eCRFs and then analysing the data and writing the clinical study report. Our data management specialists are highly experienced in handling medical and scientific data. All our data management processes are regulated according to closely controlled SOPs and in accordance with ICH GCP, FDA 21 CFR part 11 and CDISC/CDASH standards. A strong reputation for quality and excellence in these areas has resulted in our workload growing.
You must have the right to live and work in Australia to apply for this job. Datapharm Australia is Sydney based at our Drummoyne office and we are a family friendly workplace. Datapharm reserves the right not to proceed with any appointment.
Salary will be determined according to experience and qualifications.