Shire Jobs

Change people's lives and love what you do! Cochlear is the most recognized brand in hearing health care.

Clinical Project Manager I

• Application deadline: September 30, 2024

Position Spotlight:

• Oversee execution of clinical feasibility trials in support of new technology design
• Work closely with the clinical audiology and algorithm development teams to plan and execute internal clinical investigations and sponsored external studies in the US and globally
• Collaborate with cross functional teams and act as a Cochlear liaison with key industry personnel
• Hybrid work model with 2 days in office and 3 days work from home

Change people's lives and love what you do! Cochlear is the most recognized brand in hearing health care.

About the role

Cochlear is helping people hear, and be heard, all over the world. Come be a part of our amazing mission! If you have experience in clinical research, this is a fantastic opportunity to join the global leader in implantable hearing devices! In order to help Cochlear continue to grow and service our customers, we are recruiting for a Clinical Project Manager I in our Advanced Innovation division based in our head office in Lone Tree, CO.

To be successful in this role you'll be able to manage and execute sponsored clinical feasibility trials in compliance with applicable SOPs, global and local regulations including the Code of Federal Regulations (21CFR), ISO14155, International Committee on Harmonization (ICH), and Good Clinical Practice (GCP). As a Clinical Project Manager I, you will be responsible for multiple aspects of clinical operations and work in close collaboration with relevant internal and external key stakeholders, to ensure high standards of clinical study execution that deliver clinical data to support the desired ethical and evidence-based claims. You will collaborate with cross functional teams and act as a Cochlear liaison with key industry personnel including site investigators and study coordinators and assist in the generation of clinical evidence to increase industry knowledge surrounding implantable hearing technology.

Key Responsibilities

• Lead a multi-disciplinary team with support as needed in the conduct of a cost-effective, ethical and results focused feasibility study that supports the defined business objectives.
• Create and implement required study documentation and plans in line with local Institutional Review Board (IRB) or Ethics Committee (EC) requirements, local regulatory guidelines and SOPs to ensure that all studies are conducted in a compliant manner, or liaise with a Clinical Research Associate (CRA) to conduct these activities.
• Ensure audit-ready clinical study documentation and oversee the use of electronic trial master file (eTMF) .
• Create and distribute study related metrics to internal and external stakeholders including weekly and monthly updates within team, cross functional teams or senior management, and externally for clinical study sites.
• Manage site and subject enrollment, receipt of clinical data and reporting of adverse events to established timelines.

Key Requirements

To add value to Cochlear in this role you'll be able to meet and demonstrate the following knowledge, skills, and abilities in your application and at interview:

• Bachelor's degree and 3 to 5 years of clinical research experience ideally in medical device or an advanced degree in hearing science, audiology or related field and 1 to 2 years of clinical research experience ideally in medical device.
• Clinical Research certifications from ACRP or SOCRA preferred.
• Intermediate knowledge of Good Clinical Practice (GCP), International Conference of Harmonisation (ICH), Code of Federal Regulations (CFR) and ISO14155 (CITI Certification preferred).
• Experience with electronic data capture (EDC) and electronic trial master file (eTMF) systems, project planning and managing bu gets.

Total Rewards

In addition to the opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits.

• The Target Salary Range in the United States: $100,000 - $110,000 based upon experience, as well as an annual bonus opportunity of 7.5% of base salary. Exact compensation may vary based on skills, experience, and locat
• Benefit package includes medical, dental, vision, life and disability insurance as well as 401(K) matching with immediate vesting, Paid Time Off, tuition reimbursement, maternity and paternity leave, Employee Stock Purchase Plan and pet insurance.

Who are we?

Human needs have always been our inspiration, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant because he saw his father struggle with hearing loss. We always start with people in mind - thinking about their needs.