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This is a Job Description for a Clinical Project Manager I in Jackson, Mississippi
Summary: 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.
Duties & 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, cross functional 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.
Requirements
and Qualifications[]{#Hlk142289191}[]{#Hlk142304825}: 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 Harmonization (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%.
Equal
Opportunity/Affirmative Action Employer.