• Manager, Designated Complaint Unit

    Job Location US-PA-Philadelphia
    Mon-Fri, 9-5
    Regular Full-Time
  • Overview

    ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.

    Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.


    ERT is looking for a Manager Designated Complain Unit for our Philadelphia office. In this role you will be responsible for the intake of all complaints raised internal or external with respect to the development, deployment and execution of ERT products and services in accordance with ERT defined contracts and quality agreements.  You will manage a global team of Quality Engineers and is responsible for ensuring compliance and execution of the ERT Continuous Improvement program in accordance with ICH E6 GCP, 21 CFR Part 820 and ISO standards – including but not limited to 9001 and 13485.


    Essential Duties and Responsibilities:

    1. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training, and developing employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
    2. Responsible for leading a team of ERT personnel for the execution of Continuous Improvement program as it relates to complaint reporting; for assigning to his/her respective team members all valid complaints identified for management and completion.
    3. Responsible for the analysis of all incoming product/service complaints.
    4. Responsible for the maintenance as well as administration oversight/support of the complaint database, managed via a third party commercial off the shelf solution.
    5. Responsible for the routine review and revision of standard operating procedures, standard work instructions defined for the continuous improvement program.
    6. Responsible for the generation of client requested summary reports in the form of the ERT standard (e.g. CAPA).
    7. Compiles for the routine reporting, performance metrics related to the receipt and processing of client complaints. This includes but is not limited to Severity ratings such as Critical, Major, Minor, On-time completion per ERT standards, complaints by business unit, consolidation and reporting of trend data, etc.
    8. Supports, with the ERT Safety Officer(s) for Medical Devices, the investigation of any complaints identified as Death or Hazard of Death or Serious Injury. Also, the identification of complaints related to Sponsor clinical trials where data integrity, security or privacy issues have been identified.
    9. Support the investigation of any suspected instances of Clinical Misconduct/Fraud.

    Other Duties and Responsibilities:

    1. Manage, direct, deliver, or ensure delivery of training to all employees with regard to the submission and management of client complaints.

    The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  This job description and any attachments do not constitute or represent a contract.


    Qualifications and Skills Needed:

    1. Minimum 5-7 years relevant experience, 3-5 years leading a team
    2. Bachelor’s Degree or equivalent experience
    3. Strong knowledge of EU General Data Protection Regulation (GDPR) on the protection of individuals with regard to the processing of personal data and on the free movement of such data; EU Model Clauses
    4. Strong knowledge of HIPAA and other privacy and security laws, regulations, and corresponding practices
    5. General knowledge of global compliance requirements related to global geographic area – US, EU, APAC, etc.
    6. Formal education or professional experience in law, privacy, public policy, or health care; Pharmaceutical/Clinical Trial experience preferred.
    7. Experience working in environments that process personally identifiable information (PII) or protected health information (PHI)
    8. Experience establishing and maintaining privacy and security compliance in a health-related setting
    9. Excellent organizational, interpersonal, verbal, and written communication skills
    10. Ability to work effectively as part of an integrated project team, while also taking ownership of assigned tasks to successfully achieve explicit delivery dates and milestones


    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.



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