Clinical Project Manager I (Clinical Studies Team) - Cochlear

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).