Clinical Affairs Manager

Tympanogen

Tympanogen is a medical device company based in Richmond, VA with a mission to improve healthcare by simplifying surgical procedures. We develop gel-based medical devices for the ear, nose, and throat industry and transform eardrum surgery into an office-based procedure.

We are seeking an experienced Clinical Affairs Manager to lead a clinical study for one of our devices, and to support future clinical plans. This position reports to the CEO and works closely with our regulatory team to ensure the study runs effectively. An ambitious candidate with a track record of successful clinical study operations would thrive in this role.

Key Responsibilities

Develop, plan, implement, and manage clinical study activities including;

  • Project planning and clinical study design development
  • Collaboration with Leadership, Regulatory, and other functional groups or key stakeholders to establish and implement plans consistent with business objectives
  • Establish clinical study plans, timelines, and resourcing needs
  • Manage resources (internal/external) to successfully execute clinical trials within budget and schedules
  • Oversee development of core clinical documents including clinical study protocol, case report forms (CRFs), informed consent forms, and clinical study agreements
  • Participate in study site selection including ensuring appropriate qualification of investigational sites for clinical trials
  • Develop and manage study budgets efficiently with study sites
  • Negotiate clinical trial contracts with clinical study sites

Interface with Leadership, Regulatory and other functional teams or partners to provide project status reports and to ensure study plans are implemented and executed in compliance with applicable regulations, quality systems or procedure requirements, and in alignment with business objectives

Oversees all clinical study operational aspects to ensure clinical studies are conducted in compliance with the respective investigational plan and all applicable regulations, IRB requirements, and Company policies and procedures including:

  • Ensures appropriate preparation and submission of required documentation to Institutional Review Boards (IRBs) for approval. Ensures maintenance of approval throughout the duration of the study and ensures compliance to IRB reporting requirements and with national and international regulations.
  • Helps to ensure appropriate training is provided to clinical investigators and staff regarding data collection and reporting requirements as necessary.
  • Oversees data management system, including selection, development and implementation of systems to ensure the proper recording, collection, verification, validation, processing, analysis and storage of information collected in a clinical Study.
  • Oversees operation to ensure all necessary documentation, including contract agreements are executed, signed and archived.
  • Provides status reports in compliance with federal reporting requirements to regulatory agencies, IRBs, and Investigators.
  • Act as a liaison to study sites and assist or support study sites with trial execution. Activities may include site qualification visits, site initiation visits and training, monitoring visits to review the study data and verify the accuracy of the data against the site’s medical records, and site close-out visit.
  • Supports Regulatory Affairs with regulatory filings/registrations when necessary, such as but not limited to: input related to FDA submission questions, literature reviews, and development of Clinical Evaluation Reports (CERs) for design dossiers.

Experience and Qualifications

Knowledge and Skill Requirements:

  • Working knowledge of Good Clinical Practices (GCPs), FDA regulations and IRB procedures governing the conduct of human clinical research
  • Accuracy, reliability, and high level of attention to detail
  • Strong level of professionalism, including verbal and written skills
  • Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments
  • Familiarity with medical and anatomical terminology
  • Demonstrated ability to manage projects
  • Excellent organizational and interpersonal skills
  • Strong verbal and written communication skills
  • Proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint

Preferred Qualifications:

  • Bachelors degree in a relevant scientific discipline or related field
  • Minimum 5 years of clinical study experience
  • Ability to travel 20% for site visits

Sectors

  • Devices & Instrumentation
  • Clinical Research

Job Type

Full-time

Address

Remote
Upload your resume to apply for this role through CvilleBioHub. If the company accepts applications through email, they will also receive your resume.
  • Hidden
  • Your resume must be .pdf file format.
    Accepted file types: pdf, Max. file size: 100 MB.
  • Your cover letter must be .pdf file format.
    Accepted file types: pdf, Max. file size: 100 MB.
  • This field is for validation purposes and should be left unchanged.