Sr. Manager, Clinical Affairs
JOB DESCRIPTION

Personal Genome Diagnostics (PGDx) offers innovative diagnostic tests and bioinformatic systems that play a pivotal role in the groundbreaking area of next generation sequencing (NGS).

KEY RESPONSIBILITIES
  • To be successful in this role the candidate must have the ability to:
    • Manage oncology diagnostic programs for relevant regulatory submissions including, but not limited to PMA and 510(k) submissions including:
      • Protocol design and approval
      • Regulatory strategy alignment and input
      • Database and case report form (CRF) design input
      • Risk identification and mitigation
      • Study plan writing
      • Manage and execute timelines
      • Study Monitoring
      • IRB submissions and management
      • Study binder production, maintenance and audit readiness prep
      • Clinical Affairs representation at the Project Team level
      • Align and work cross-functionally within the org to optimize execution
    • Monitor clinical studies and investigational sites for adherence to the protocol, GCP/ICH, and company SOPs
    • Prepare and perform site initiation visits, routine monitoring visits and site close out visits for each of assigned studies
    • Review clinical study related documents including the informed consent forms (ICF), source documents, patient instruction guides and CRFs
    • Assist in investigational site identification and perform site qualification visits as needed
    • Monitor progress of clinical studies, develop progress reports for the project team (e.g. patient accrual, audit reports and findings, data transmission and data reporting activities)
    • Ensure quality of data generated from clinical sites and assist in resolving patient eligibility and protocol deviation issues
    • Serve as liaison and resource for assigned investigational sites
REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor's degree in a Life Science, Biological Science or other related medical degree and five (5) plus years of related work experience
  • IVD experience
  • Working knowledge of clinical research processes, regulatory requirements, data collection requirements and methodologies
  • Knowledge of Good Clinical Practices/ICH and SOPs
  • Ability to travel domestically and internationally (up to 30% may be required)
  • SoCRA or ACRP or similar certifications are desirable
ABOUT PERSONAL GENOME DIAGNOSTICS

Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide. PGDx was established by internationally-recognized cancer researchers Dr. Luis Diaz and Dr. Victor Velculescu, who are pioneers in the application of innovative genomic technologies for drug development and clinical practice.

Please submit applications (cover letter and resume) to HR@personalgenome.com Special consideration will be given to internal PGDx employees who apply.

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