Job typeFull-timeBenefits & Perks
- Health insurance
- Paid sick time
BenefitsPulled from the full job description
- Health insurance
- Paid sick time
Full job description
As a Clinical Data Coordinator-II you will be actioning all tasks relating to Clinical Data Management from the start to the finish of a study and to support Project Manager in studies across DM functions.
Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers’ needs.
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Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development
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We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Responsibilities
- To assist in the testing of databases prior to activation.
- To assist in the preparation of study specific documentation as appropriate.
- To critically review CRFs as specified in the Data Management Plan and to query any errors or omissions with either the study sponsor or the investigator as required.
- To track and resolve Data Clarification Forms in the study specific Database.
- To resolve Self-Evident Queries/Allowable Changes in the study specific Database.
- To perform the Quality Control of Data Entry and CRF/database as appropriate.
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- To prepare any documentation for return to client/internal archiving at study completion as requested.
Requirements
- Extensive knowledge of at least 2 Clinical Data Management systems such as Oracle Clinical, Medidata Rave, Inform.
- 3-6 years of relevant core Clinical Data Management experience within Pharmaceutical/ CRO industry
- Extensive experience in Clinical data management activities from the start to the finish of a study
- Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
Benefits
Competitive Salary (Open to discussion based on experience)
Flexible working hours
Annual leave plus casual, sick leave
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Medical Insurance
Accidental Coverage
5, 10, 15 years of service recognition awards
Death in service scheme
Long Term Disability Insurance
Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e-learning, job shadowing)
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