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AOA Press Release

AOA Dx is Seeking a Director of Clinical Operations to Lead its Clinical Programs 

April 4, 2022

Director, Clinical Operations

 

AOA is seeking a driven Director of Clinical Operations to lead the overall execution of clinical programs and to build high-quality clinical operations programs within AOA. The Director of Clinical Operations will report to the Chief Business Officer and will be responsible for the planning and execution of all clinical development and studies. Primarily, the chosen individual will be responsible for activities pertaining to the day-to-day management and execution of large US prospective trials for FDA approval. Experience with this level of responsibility is required. 

 

This is a critical and highly visible role at a fast-growing organization. The successful candidate will have experience for the complete management of clinical trial execution which includes managing clinical sites, vendors (CROs), and collaborating with internal and external stakeholders.  

 

Responsibilities:

  • Lead all clinical operational aspects of a clinical trial from protocol, clinical agreements, start-up, training, maintenance, and close-out.

  • Responsible for the day-to-day management and execution of a large US multi-center prospective trial designed to obtain FDA approval. 

  • Liaise closely with the regulatory team throughout the development and completion of clinical trials.

  • Contribute to development and responsible for maintaining study-related plans and documents including clinical study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, protocol deviations plans, case report forms, clinical study reports (CSRs), clinical sections of regulatory documents, briefing books and drafting responses to Health Authorities. 

  • Maintain an overview of status, issues, risk and proactively communicates progress, issues, changes, or risk mitigation strategies that may impact timelines and cost of the program to stakeholders.

  • Contribute to overall Clinical Development Plan (CDP) that meets the strategic objective of the company.

  • Manage clinical operations which include creating standard operating procedures, aiding in IRB submissions, clinical study monitoring and data acquisition. 

  • Partner with R&D team and senior management to ensure goals, deliverables and objectives are met. 

  • Develop a data management strategy for clinical studies that allows for easy data abstraction, analysis, collaboration and interaction with R&D.

  • Be responsible for working with multiple clinical partners and vendors to complete clinical trials

  • Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other relevant vendors to ensure successful trial implementation and execution.

  • Ensure proactive management of CRO to deliver on established timelines, budget and quality expectations. 

  • Responsible for selection, qualification, and management of vendors to support clinical trial execution

  • Develops and manages comprehensive study timelines and metrics and ensures completion of study deliverables

  • Proactively identifies and resolves clinical project issues             

 

Requirements:

  • Bachelor’s Degree

  • 5+ years experience leading clinical operations in medical diagnostic or medical device company with successful track record of well-executed clinical studies 

  • Strong experience with FDA 510k/PMA, CE-IVDR and lab-developed test diagnostic clinical trials

  • Strong project management experience and best practices 

  • Working experience with electronic data capture systems 

  • In-depth understanding of human subject research and knowledge of FDA/CMS/LDT Regulations 

  • Primarily remote position

  • Up to 50% travel, as needed

Application:

 

Please submit your resume to info@aoadx.com to apply. 

 

 

About AOA Dx Inc.

AOA Dx Inc (AOA Inc) is a US company, with teams based in Boston, New York and London developing cancer diagnostics in the field of women’s health. AOA Dx Inc, a female led company, is committed to bringing the first accurate early stage liquid biopsy ovarian cancer diagnostic test to market that will improve clinical practice, help reduce patient mortality and deliver cost savings to payers. More information can be found at www.aoadx.com.

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