Senior Clinical Data Manager

Sydney - Australia

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Please submit your application as soon as possible as we reserve the right to close this advertisement at any time.

Cochlears mission is to help people hear and be heard. As the global leader in implantable hearing solutions Cochlear is dedicated to helping people with moderate to profound hearing loss experience a world full of sound. We aim to transform the way people understand and treat hearing loss and innovate to connect people with future technologies. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to peoples lives. Learn and grow with us as we tackle the most complex challenges in helping more people to experience a lifetime of hearing.

The Opportunity

An opportunity exist to join Cochlear as an experienced Senior Clinical Data Manager to lead the end-to-end delivery of clinical data projects for global Cochlear-sponsored studies. This pivotal role ensures high-quality data management from database setup through to database lock supporting Cochlears clinical evidence strategy.

Reporting to the Senior Manager of Clinical Data Operations you will work with structured and unstructured data from diverse sources including clinical investigations post-market follow-up and anonymized clinic submissions. Beyond technical expertise youll provide mentoring training and guidance to team members while collaborating with stakeholders across the organisation.

Your responsibilities include:

Database Design & Management: Build configure and validate EDC systems; design eCRFs patient diaries and questionnaires.
Data Quality Assurance: Ensure timely accurate and complete data collection; manage data cleaning and database lock.
Documentation: Create and review Data Management Plans (DMP) CIP and other study-specific documents.
Reporting & Analysis: Develop and analyse reports for study conduct metrics and data visibility.
Continuous Improvement: Drive process enhancements SOP development and mentor team members.

About You.As we grow our operations we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role youll be able to demonstrate the following skills and experience:

Expertise in Electronic Data Capture (EDC) systems and clinical data management.
Strong analytical skills with proficiency in SQL R Python or similar tools.
Excellent communication and stakeholder management skills.
Proven project management and organizational capabilities.
Experience with Veeva CDMS.
Knowledge of ISO 14155 ICH-GCP and regulatory requirements.
Ability to train and coach team members and non-technical users
Bachelors degree in Life Sciences IT or Biomedical Engineering.
Minimum 5 years experience in clinical investigations within medical device pharma or biotech industries.

If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear please start your application by clicking the apply button below.

#CochlearCareers

How we recognise your contribution

At Cochlear we value and welcome the unique contributions perspectives experiences and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences creating a sense of belonging and enabling our people to realise their full potential. Through our internal programs and employee benefits we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments then we have several programs in place to support you.

For more information about Life at Cochlear visit

Required Experience:

Manager

Please submit your application as soon as possible as we reserve the right to close this advertisement at any time.Cochlears mission is to help people hear and be heard. As the global leader in implantable hearing solutions Cochlear is dedicated to helping people with moderate to profound hearing lo...

Please submit your application as soon as possible as we reserve the right to close this advertisement at any time.

The Opportunity

Your responsibilities include:

Database Design & Management: Build configure and validate EDC systems; design eCRFs patient diaries and questionnaires.
Data Quality Assurance: Ensure timely accurate and complete data collection; manage data cleaning and database lock.
Documentation: Create and review Data Management Plans (DMP) CIP and other study-specific documents.
Reporting & Analysis: Develop and analyse reports for study conduct metrics and data visibility.
Continuous Improvement: Drive process enhancements SOP development and mentor team members.

Expertise in Electronic Data Capture (EDC) systems and clinical data management.
Strong analytical skills with proficiency in SQL R Python or similar tools.
Excellent communication and stakeholder management skills.
Proven project management and organizational capabilities.
Experience with Veeva CDMS.
Knowledge of ISO 14155 ICH-GCP and regulatory requirements.
Ability to train and coach team members and non-technical users
Bachelors degree in Life Sciences IT or Biomedical Engineering.
Minimum 5 years experience in clinical investigations within medical device pharma or biotech industries.