Clinical Data Manager

5 days ago

Brisbane, Australia Avance Clinical Full time

Great company culture
- Variety of therapeutic areas
- Flexibility to work anywhere

**Avance Clinical - our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respects its people.**
Avance Clinical is a Contract Research Organisation which offers specialised services supporting clinical drug development for the pharmaceutical and biotechnology industry.

**The Opportunity**
If you are an experienced Clinical Data Manager, are passionate about data management in a clinical research setting and want to work in a challenging and stimulating environment where what you do matters, then we want to hear from you now.
You will be responsible for capturing and documentation of clinical research data as per the study protocol. The position works collaboratively to make sure data is collected, managed and reported clearly, accurately and securely.
This is a permanent full-time position which can be worked home based from anywhere in Australia or home or office based in Adelaide.

**Responsibilities**
- Preparation of Data Management Plans.
- Preparation or review of Edit Check Document.
- Development and review of Case Report Forms (CRFs) and completion guidelines in line with the database and protocol.
- Preparation of clean and erroneous dummy data.
- Database Validation (testing data entry screens and edit checks using dummy data).
- Provide training to site, Sponsor and other staff in the use of eCRF systems.
- Resolution of Quality Assurance (QA) comments.
- Perform data review and cleaning of data collected during the trial.
- Perform Quality Control on study data prior to lock.
- Act as Data Project Manager including interaction with Clinical Project Manager, interact with site/ client/ external vendors, perform overall Project Management and timeline management.

**What you’ll need to succeed**
- Ordinary degree in the appropriate discipline or equivalent experience.
- Minimum 2 years experience in the pharmaceutical industry / CRO working in a GCP environment.
- Experience with Medrio and/or Medidata Rave is desirable.
- Knowledge of ICH GCP Guidelines, medical terminology and clinical trials process.
- Experience in EDC/e-CRF systems_._
- Intermediate MS Office Suite.

**Benefits**
- Reputable growing CRO with stability
- Challenging and stimulating environment where what you do matters
- A diverse and inclusive culture with a strong emphasis on team collaboration
- Training and career development opportunities
- Attractive remuneration

**To apply**
- You must also have full Australian working rights to be considered.
- No agencies please

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