Clinical Data Specialist
Job no: 612727
Work type: Permanent
Categories: Clinical Studies, Oceania, Individual Contributor
Cochlear is the global market leader in implant hearing solutions and is a top 50 company on the ASX. Cochlear's mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It’s an incredible piece of engineering and the only product in the world that restores a sense through technology.
We are currently looking for a Clinical Data Specialist to join us in our global headquarters in Macquarie University on a permanent full-time basis.
The Clinical Data Specialist is an expert responsible for developing data capture tools and the provision, verification, analysis and reporting of high quality clinical data.
- Design, set up, validate, maintain and document studies in the clinical investigations data capture system according to the requirements specified in the Clinical Investigation Plan (CIP), Cochlear data standards and Cochlear standard operating procedures (SOPs)
- Collaborate with Clinical Project Managers to design eCRFs, patient diaries and questionnaires, and associated data quality checks, in line with our clinical data standards and global library of forms, to ensure that high quality data will be collected during clinical investigations.
- Co-ordinate user acceptance testing, validation, and signoff of data capture tools, including active participation in unit testing of other colleagues’ studies.
- Facilitate the collection of high quality clinical investigation data, including review of data according to the data quality checks defined for the clinical investigation and Cochlear SOPs, status reporting and database lock.
- Run and analyse reports to support clinical investigation conduct, visibility and reporting of clinical data. Reports may include data listings, metrics, study updates, ad hoc reporting and standardised reporting. Development shall include determining the reporting requirements and liaising with appropriate stakeholders, as well as designing, creating, testing and validating the reports.
- Collaborate globally to develop and introduce process and documentation improvements for the Clinical Data Management and clinical investigation teams.
You will bring:
- A minimum of 2 years’ experience in clinical investigations in the device, pharmaceutical or biotechnology industries with a firm understanding of the device development process
- Life sciences or Information Technology graduate, or equivalent
- Experience with Electronic Data Capture (EDC) or other clinical data management systems
- Demonstrated experience defining, testing, validating and managing information technology systems, with a commitment to meeting the needs of technical and non-technical end users
- Demonstrated logical and methodical approach to creating high quality data capture tools and supporting materials
- Demonstrated ability to provide technical and procedural training and coaching as required
- Excellent analytical and conceptual thinking skills with high attention to detail
- A firm understanding of ISO 14155 or ICH-GCP, 21 CFR Part 11 and regulatory requirements applicable to clinical investigations in the medical device industry
- Strong interpersonal and communication skills, both verbal and written
- Demonstrated organisation and planning skills
- Willing to travel locally and internationally as required
- Able to work effectively independently, and as a member of a team
- Experience with the CDISC data standards (CDASH and SDTM)
- MedDRA, IMDRF or WHO-ATC Coding experience
- Ability to manage and analyse datasets using Tableau, SQL, Python or other reporting software, preferably with clinical data
- Exposure to clinical investigation monitoring
- Comfortable presenting to small and medium audiences
- Be part of a mission-led company where we help transform the way people understand and treat hearing loss
- Part of a collaborative team, where your ideas will have a direct impact on our global team
- Flexible work arrangement
- Free onsite parking
- Very stable company, with high growth projections
Cochlear will offer you the opportunity to continuously improve your skills in a globally active high-tech manufacturing environment. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people's lives. Take the first step towards a career you can be proud of. Apply online today.
Advertised: AUS Eastern Daylight Time
Anticpated Application Closing: AUS Eastern Standard Time
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