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 Harmonisati n (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
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