Clinical Project Manager I (Clinical Studies Team)
Cochlear

Job Info

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

Clinical Project Manager I (Clinical Studies Team)

• Application Deadline: October 4, 2024

Position Spotlight:

• Lead a multi-disciplinary team in Class II and Class III medical device clinical trials
• Oversee execution of a clinical trial to ensure Investigator Compliance
• Travel is required at 30% to support site visits

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 medical device or pharmaceutical 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 Americas head office based in Lone Tree, CO offering a hybrid of remote work environment depending on place of residence.

To be successful in this role you'll be able to manage and execute Class II and Class III medical device clinical 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 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 such as Regulatory, Product Marketing, Health Economics and Quality and act as a Cochlear liaison with key industry personnel including site investigators and study coordinators in the generation of clinical evidence that increases industry knowledge surrounding implantable hearing technology.

Key Responsibilities

• Lead a multi-disciplinary team in the conduct of a cost-effective, ethical and results focused, publishable study that supports the defined business objectives.
• Oversee Site Qualification, Site Initiation, Interim and Close-out Monitoring Visits to ensure Investigator Compliance.
• Liaise with Clinical Research Associate (CRA) to create and implement required study documentation and plans including the study protocol 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.
• Manage site and subject enrollment, receipt of clinical data and reporting of adverse events to established timelines.
• Act as primary contact between clinic trial sites and sponsor for all study specific needs including routine investigator updates.
• Create and distribute study related metrics to internal and external stakeholders including weekly and monthly updates within team, crossfunctional teams or senior management, and externally for clinical study sites.
• Anticipate potential obstacles to clinical study success, prepare and communicate contingency plans and implement process improvements.

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 medical device or pharmaceutical clinical research experience or an advanced degree in hearing science, audiology or related field and 1 to 2 years of medical device or pharmaceutical clinical research experience.
• 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 budgets.
• Travel is required at 30%.

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 location.
• 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.

For this reason, our products, services and support will continue to evolve and improve. We are by our customers' side through the entire hearing journey, so they can experience a life full of hearing. 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 and working in an organization where they can be part of bringing the mission to life each day.

Physical & Mental Demands

The physical and mental demands described below are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the individual is regularly required to be in a stationary (seated/standing) position; utilize business technology for work product delivery, communicate orally and in writing with others internal or external to the organization, utilize problem solving/critical thinking skills to discern and convey information. May be asked to occasionally transport/move up to 25 pounds, depending on the position. Specific vision abilities required by this job include ability to adjust focus. The individual is regularly required to utilize comprehension, critical thinking, communication, problem solving, organization reasoning, relating to others and discernment of items such as product specifications, procedures and processes to customers (whether internal or external). Influence, organization/classification of information and planning are also required.

The work environment is a home/office environment and represents those an individual may encounter while performing the essential functions of this job.

Apply now by completing your application form online. Applicants must meet the job specific application criteria to be considered. Visit our careers site at www.cochlear.us/careers to learn more.

Cochlear Americas is an Equal Opportunity, Affirmative Action Employer and provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, marital status, veteran status, or any other characteristic protected by federal, state or local law. In addition, Cochlear will provide reasonable accommodations for qualified individuals with disabilities. If you require accommodation with completing the online application, please contact us via web or phone at 303-264-2549.

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