Clinical Safety Manager

2 months ago

Sydney, Australia Cochlear Ltd Full time

Cochlear is the global market leader in implant hearing solutions. 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. Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help more people to hear.

The Clinical Safety Manager will work collaboratively with Data Management, Clinical Project Managers and Clinical SMEs such as Technical Field staff, Research Audiologists, Research & Development Engineers, and Quality Post Market Surveillance. They will facilitate the review of Adverse Events and Device Deficiencies by appointed Clinical Safety Monitors and coordinate individual case processing and reporting to regulatory authorities and Investigators.

The Opportunity

Cochlear has a permanent ongoing opportunity for a Clinical Safety Manager based in our Sydney, Macquarie office. In this role, the successful Clinical Safety Manager is primarily responsible for coordinating processes for safety monitoring and reporting for clinical studies and marketed products.

Responsibilities include:

- Escalate potential safety risks through the Clinical Review Board to ensure appropriate quality control procedures are considered and applied.
- Proactively communicate when there may be periods requiring back-up support or assistance to achieve the accountabilities of the role.
- Continually seek to raise the awareness and understanding of clinical investigation safety management requirements through day-to-day dealings with internal and external stakeholders.
- Demonstrate due diligence commitment to workplace health and safety through active involvement and implementation of Cochlear’s WHS and Injury management procedures.
- Contribution to clinical investigation documentation through specialist input to safety-related items, and quality control checks.

What makes this opportunity unique?

The Clinical Safety Manager will raise the profile of clinical safety management with internal stakeholders and lead process development and enhancement relating to Clinical Safety processes. This may include growth of a team directly reporting to the Clinical Safety Manager.

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, you'll be able to demonstrate the following skills and experience:
Essential

Minimum:

- Bachelor of Biomedical or Health Sciences, Nursing, Pharmacy, Pharmacology, or related discipline.
- Experience working alongside or in clinical data management and/or safety vigilance.
- Has experience in and is comfortable navigating complexity and ambiguity in business processes and structure
- Experience in MedDRA coding and handling of safety data.
- Ability to work independently and part of a cross functional team.
- Excellent interpersonal, written, and verbal communication skills with ability to communicate with internal stakeholders and external customers.
- Strong attention to detail with ability to manage priorities ensuring quality and timeliness of work.
- Proficiency in MS Office

Ideal:

- Working knowledge of GCP (good clinical practices), medical terminology, clinical research conduct and applicable legislation and standards.
- Experience in clinical scientific or medical writing.
- Experience in the development of process/procedures.

Cochlear’s 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 life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry’s best clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life’s opportunities.

CochlearCareers

How we recognise your contribution

We want Cochlear to be a place where our people truly enjoy coming to work. 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

  • Clinical Safety Manager

    2 weeks ago

    Sydney, New South Wales, Australia Cochlear Ltd Full time

    Cochlear is the global market leader in implant hearing solutions. 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...

  • In-house Clinical Research Associate

    4 weeks ago

    Sydney, Australia Advanced Clinical Full time

    In-House Clinical Research Associate (Australia-wide) **Location**: Sydney NSW, Australia **Requisition Number** **345** **Remote** Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched...

  • In-house Clinical Research Associate

    4 weeks ago

    Sydney, Australia Advanced Clinical Full time

    In-House Clinical Research Associate (Australia-wide) **Location**: Sydney NSW, Australia **Requisition Number** **345** **Remote** Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched...

  • In-house Clinical Research Associate

    2 weeks ago

    Sydney, New South Wales, Australia Advanced Clinical Full time

    In-House Clinical Research Associate (Australia-wide)Location: Sydney NSW, AustraliaRequisition Number345RemoteAdvanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research -...

  • Education and Clinical Lead, Infection Prevention

    3 weeks ago

    Sydney, Australia NSW Clinical Excellence Commission Full time

    **Education and Clinical Lead, Infection Prevention and Control (IPAC)** **Clinical Excellence Commission** **Where you'll be working** The Clinical Excellence Commission (CEC) is committed to providing leadership in safety and quality to improve health care for patients in NSW. The primary focus of the CEC is to promote and support improved clinical...

  • Clinical Research Associate, Cns, Rare Diseases

    2 weeks ago

    Sydney, New South Wales, Australia Worldwide Clinical Trials Full time

    Requisition Number6072Employment Type:RegularDo you have a passion for mentoring the Next Generation of CRAs field monitors? Are you looking for a position where you will be groomed for a leadership role? If so, this Job Is For YOU. Feel the reward of impacting someone else's career while preparing for a leadership role in clinical trials. Our hiring...

  • Improvement Lead, Medication Safety and Quality

    2 weeks ago

    Sydney, Australia Clinical Excellence Commission Division Full time

    **Improvement Lead, Medication Safety and Quality** **Clinical Excellence Commission** **Where you'll be working** The Clinical Excellence Commission (CEC) is committed to providing leadership in safety and quality to improve health care for patients in NSW. The primary focus of the CEC is to promote and support improved clinical care, safety and quality...

  • Medical Monitor

    2 months ago

    Sydney, Australia Advanced Clinical Full time

    Medical Monitor (Australia-Wide) **Location**: Sydney NSW, Australia **Requisition Number** **351** **Remote** Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research...

  • Medical Monitor

    4 weeks ago

    Sydney, Australia Advanced Clinical Full time

    Medical Monitor (Australia-Wide) **Location**: Sydney NSW, Australia **Requisition Number** **351** **Remote** Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research...

  • Manager Clinical Safety and Quality

    4 days ago

    Sydney Olympic Park, Australia Ambulance Service of NSW Full time

    **Employment Type**: Permanent Full Time, 38 hours per week **Position Classification**: Health Manager Level 3 **Remuneration**: $122,850 per annum - $139,559 per annum + super and annual leave loading **Location**: State Operations Centre, Sydney Olympic Park **Closing Date**:17 June 2024 **ABOUT US** NSW Ambulance is an integral part of the NSW Health...

  • Medical Monitor

    2 weeks ago

    Sydney, New South Wales, Australia Advanced Clinical Full time

    Medical Monitor (Australia-Wide)Location: Sydney NSW, AustraliaRequisition Number351RemoteAdvanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each...

  • Principal Clinical Lead, Patient Safety

    4 days ago

    Sydney, Australia NSW Health Full time

    **Principal Clinical Lead, Patient Safety** **Clinical Excellence Commission** **Where you'll be working** The Clinical Excellence Commission (CEC) is committed to providing leadership in safety and quality to improve health care for patients in NSW. The primary focus of the CEC is to promote and support improved clinical care, safety and quality across...

  • Proposal Manager, Laboratory

    2 weeks ago

    Sydney, New South Wales, Australia GreenLight Clinical Full time

    Position:Proposal Manager - Lab**Reports to: Head of Finance**Why you're hereThe objective of your role is to:Win new business for Greenlight Clinical's (GLC) Laboratory and Clinical Research Organisation. Collaborate with the Business Development and Proposals teams, Laboratory Management and Scientists, Finance, and the broader team to deliver winning...

  • Stats Programming Team Manager

    4 weeks ago

    Sydney, Australia Avance Clinical Full time

    Remote or office based positions - Global CRO - Reputable organization with growth opportunities! Avance Clinical is a Contract Research Organisation which offers specialised services supporting clinical drug development for the pharmaceutical and biotechnology industry. The Statistical Programming Team Manager is responsible for the oversight of...

  • Contracts Manager

    2 weeks ago

    Sydney, New South Wales, Australia Avance Clinical Full time

    Based anywhere in Australia Opportunity for growth and development Global CRO with a fantastic reputationWho are we?We're Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the...

  • Stats Programming Team Manager

    2 weeks ago

    Sydney, New South Wales, Australia Avance Clinical Full time

    Remote or office based positions Global CRO Reputable organization with growth opportunitiesAvance Clinical is a Contract Research Organisation which offers specialised services supporting clinical drug development for the pharmaceutical and biotechnology industry.The Statistical Programming Team Manager is responsible for the oversight of statistical...

  • Health Safety

    2 weeks ago

    Sydney, New South Wales, Australia Safety People Full time

    Flexible Hybrid model Lead the way in implementing and maintaining safe practices Perm FulltimeHealth Safety and Environment Co-ordinatorAre you looking for a great chance to become a part of an Industry Leading organisation? Supporting a team's journey towards fostering a culture of safety excellence and advancing your career in Risk Management? If that's...

  • Quality Assurance Manager

    2 weeks ago

    Sydney, New South Wales, Australia Scientia Clinical Research Full time

    Location: Sydney.CBD, Inner West & Eastern Suburbs Industry: Healthcare & MedicalClinical/Medical Research Position:Full time Description: Please see the position details below and use the below form to apply." * " indicates required fields First name * Family name Email * Attach Resume * Drop files here or Accepted file types: doc, docx, xls, xlsx, pdf,...

  • El2 Program Manager, Medicines Safety and Quality

    2 weeks ago

    Sydney, Australia Australian Commission on Safety and Quality in Health Care Full time

    The Medicines Safety and Quality (MSQ) Program contributes to achievement of deliverables for the safe clinical processes stream of the Commission’s Work Plan. This includes action and guidance to support safe and quality use of medicines. The MSQ Program also supports the Commission’s contribution to implementation of the National Medicines Policy and...

  • El2 Program Manager, Medicine Safety and Quality

    2 weeks ago

    Sydney, Australia Australian Commission on Safety and Quality in Health Care Full time

    The Manager, Medicines Safety and Quality is responsible for managing the program of work associated with the development of national policy content, guidance, information, and communications about key quality use of medicines issues with a focus on primary care. The Manager provides oversight and management of a team that reviews and analyses emerging...