Clinical Data Management Specialist
Job no: 611882
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 Management Specialist to join us in our global headquarters in Macquarie University on a permanent full-time basis.
Reporting to the Principal Clinical Data Strategist, you are responsible for ensuring the completeness, quality and integrity of clinical data collected in clinical investigations, and to ensure that data is captured accordance with Cochlear SOPs and regulatory requirements.
- Collaborate with Clinical Project Managers and CRAs to ensure clinical investigation data is captured in a timely manner, is complete and is of high quality
- Collaborate with the Clinical team and Clinical Data Specialists to ensure that eCRFs, patient diaries, questionnaires, and associated data quality checks support high quality data capture
- Collaborate with the Clinical team to review key documents, including the CIP, specifications and other materials from a data capture and data quality perspective.
- Project manage user acceptance testing, validation, and signoff of data capture tools.
- Design, set up, validate, maintain and document studies in the clinical investigations electronic data capture (EDC) system
- Work with the Clinical Data Specialists to define, develop and analyse reports to support clinical investigation conduct, visibility and reporting of clinical data
- Collaborate globally to develop standard timelines and metrics, standard CRFs with associated data structures and data quality checks, standard reports, SOPs and templates
- Demonstrated expertise with Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS)
- A demonstrated understanding of ISO 14155 or ICH-GCP, 21 CFR Part 11 and regulatory requirements applicable to clinical investigations in the medical device industry and their implications for study design and execution
- A minimum of 2 years’ experience in clinical investigations/studies in the device, pharmaceutical or biotechnology industries with a firm understanding of the device development process
- Demonstrated project management, organisation and planning skills
- Demonstrated stakeholder management and engagement
- Strong interpersonal and communication skills, both verbal and written
- Willing to travel locally and internationally as required
- Experience building studies in Medidata Rave
- Experience supporting an eTMF or CTMS
- Exposure to the CDISC data standards (CDASH and SDTM)
- 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.
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