Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Responsible for coordinating and executing clinical trials from design to final report for in vitro diagnostic (IVD) assays of new or marketed devices in a Dx platform area internally and working with external partners. Manages two or more projects to obtain the expected high-quality results within defined project boundaries of budget, scope and schedule. Functions within multiple programmatic areas, including Molecular, Immunoassay or Blood chemistry, Coordinates the activities of functional groups including, but not limited to: project management, clinical monitoring, data management, biostatistics, biospecimen sourcing, and quality assurance to ensure proper conduct, timely and high-quality project completion Applies best practices including Project Management as a discipline, Good Clinical Practice (GCP) and other regulatory requirements in the design, development, conduct, control and closing of a project.

Tasks/Duties/Responsibilities:

Lead and manage a project that includes a team of clinical operations professionals in the design, development and execution of clinical trials per GCP and other applicable regulatory requirements.
• Manage multiple projects in the development and execution of clinical trials per GCP and other applicable regulatory requirements.
• Contribute to the forecast and management of timelines, resources and budgets for the project.
• Adhere to governmental regulations and guidance for the conduct of clinical activities and studies.
• Identify appropriate clinical trial sites, Contract Research Organizations (CRO), and development of contracts.
• Develop clinical protocol/amendments, Case Report Forms, and clinical trial testing and training plans. Facilitate IRB submissions and informed consent reviews when needed.
• Ensure clinical trial is initiated, conducted and closed according to schedule. Take part in clinical trial site visits, including qualification, initiation, training, monitoring/audits, and close-out visits when needed.
• Manage the collection, compilation and review of clinical trial data.
• Write clinical sections of regulatory 510(k)/CLIA Waiver pre-submissions; clinical reports, and other necessary reports required for regulatory submissions, such as 510(k)s, PMAs, IDEs, CLIA Waivers and associated amendments.
• Plan and verify that appropriate statistical methods and techniques are applied for the evaluation of clinical data.
• Track progress and anticipate risks to the clinical trial.
• Stay abreast of changes in regulatory requirements.
• Take part in special projects and/or initiatives identified by the Clinical Operations function or broader organization.
• Contribute to the development of Project Management, GCP/Regulations, Subject matter quality procedures, templates, and tools

Other Duties/Physical Requirements:

• Physical and Mental
  
  • Ability to walk up and down several flights of stairs throughout the workday.
  • Ability to sit for long periods of time, stoop, reach, bend throughout the course of the workday.
  • Must be able to concentrate, analyze and solve complex issues throughout the course of the workday.
  • Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.
• Other
  
  • Clinical trials will involve materials that are considered potentially biohazardous. Willing to work with hazardous chemicals and biological agents with proper protective equipment.
  • Must be able to adhere to applicable biosafety practices when on the manufacturing floor or in laboratories.

Minimum Education or Equivalent Experience Required/Preferred:

• Bachelor's degree in biological sciences required; MS degree preferred.
• Minimum 7 years of combined experience in more than one of the following disciplines Clinical Operations, Medical Affairs, R&D, Regulatory Affairs or equivalent functions
• At least 5 years managing clinical trials (e.g., essential documents/sites/data/TMFs, etc.); experience working for a sponsor organization preferred.
• International trial experience preferred.
• Prior experience preparing clinical reports for regulatory submissions (e.g., 510(k), PMA, IDE) required.
• Experience in in vitro diagnostics of clinical chemistry and/or infectious diseases required.
• ACRP/SoCRA and/or RAC certification and/or experience working in a CLIA certified clinical laboratory an asset.
• PMP certification preferred

Competencies Required or preferred:

• Highly motivated, agile, solutions driven and able to prioritize workloads to meet strict critical deadlines and project timelines.
• Demonstrated ability to manage projects, motivate team members, assign tasks and deliver quality clinical data within project constraints (time, cost, resources).
• Proven ability to communicate clearly and effectively with management, peers as well as other internal and external stakeholders.
• Demonstrated ability to clearly and succinctly write on scientific or regulatory subjects.
• Capable of understanding statistical analyses.
• General knowledge of clinical laboratory sample collection, processing and testing techniques.
• Experience in GCP, human subject protections, the requirements of informed consent, and IRB oversight of clinical investigations involving human subjects is an absolute requirement.
  
  • Demonstrated knowledge of applicable U.S. regulatory requirements for conducting clinical trials, including Title 21 CFR Parts 11, 50, 54, 56 and 812
  • Demonstrated knowledge of ICH E6(R2) Good Clinical Practice, and ISO 14155 - Clinical investigation of medical devices for human subjects
  • Familiarity with international requirements for conducting clinical trials; for example, Health Canada requirements for Investigational Testing Authorizations (ITA).
• Familiarity with clinical laboratory quality systems; for example, CLIA '88 (Title 42 CFR Part 493) and ISO 15189 Medical laboratories - Requirements for quality and competence.
• Demonstrated knowledge of Clinical Data Management Systems, EDC and eTMF.

Required Travel %:

• 30% Travel required

*We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing. (USA Only)*