Clinical Quality Operations Consultant

4 weeks ago

Boston, United States Softworld, a Kelly Company Full time

Job Title: Clinical Quality Operations Consultant

Job Location: Boston MA 02210 Remote

Job Description:

  • The Clinical Quality Operations Consultant conducts quality assurance oversight and management activities of clinical trial operations to ensure trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and policies and procedures.
  • These activities include the development and execution of study level audit plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, monitoring quality issues and compliance metrics, investigation and CAPA management, and proactive inspection readiness activities.

Key Duties & Responsibilities:

  • Develops risk-based audit plans for assigned programs, ensures audits are conducted in accordance with the plan, reviews audit reports, evaluates responses and CAPA plans in accordance with company standards and policies.
  • Identifies risks and impacts as part of vendor and clinical site oversight.
  • Communicates risks, impacts, and options to Quality and Clinical Management
    Liaise with clinical functions and external parties including CROs, Vendors and investigator sites to promote high level of quality and consistency across and within programs.
  • Provides QA review of protocols, study plans and participates in Operational meetings to identify operational risks and collaborates with study team in development of risk mitigation strategies.
  • Manages and/or leads domestic and international audits for Clinical Investigators, to ensure compliance to ICH GCP, applicable regulations, and company standards.
  • For assigned programs/ studies, leads quality issue investigations, root cause analysis and CAPA development and assist study teams in implementing corrective and preventive actions in support of sustainable compliance.
  • Assist in TMF audits and/or TMF QC activities to help identify and close gaps.
  • Contributes to the development and implementation of continuous quality improvement initiatives.
  • Engages with study teams and functions for proactive inspection readiness across assigned programs.
  • Provides inspection support as necessary for Regulatory Agency inspections held at facilities or Clinical Investigator sites.
  • May serve as GCP Quality Management System representative
    • Participates in collaborative review of impacted SOP/WI
    • Reviews and analyzes key Performance Indicator data and trends - Analyzes risk and proposes remedial, corrective and /or preventive actions
    • May participate on process improvement initiatives
  • Develop and maintain QA to QA relationships with GCP Vendors to conform to quality agreements, and participates in applicable Vendor Joint Operating Committees, as needed.

Required Education Level:

  • Bachelor's degree in scientific or allied health discipline

Required Knowledge/Skills:

  • Typically requires 10+ years of experience or the equivalent combination of education and experience
  • In-depth knowledge of ICH GCP R2 and applicable global regulations and guidance for clinical development (e.g., FDA regulations, EU Regulations and Directives, MHRA Statutory Instruments, etc.)
  • Strong experience with all phases of clinical trial development involving drugs.
    In-depth knowledge of Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness Checks.
  • Ability to understand and translate customer needs, bringing a new perspective to existing quality management solutions
  • Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.
  • Ability to work independently with minimal guidance, organizing and prioritizing work effectively for timeliness, accuracy and quality
  • Proficient in managing complex projects, achieving goals and deadlines.
  • Proficient in using Microsoft Office applications is an asset (MS Word, MS Excel, MS PowerPoint, Visio)
  • Strong experience with key performance indicators, metrics analysis, and monitoring/trending of quality and compliance metrics

  • Quality Consultant

    3 months ago

    Boston, United States RQMIS Inc Full time

    Job DescriptionJob DescriptionRQMIS, Inc. is a fast growing, medical device/biotechnology consultancy with as focus on regulatory strategy/submissions, clinical study design/management and quality systems design/compliance/auditing. We are looking for an experienced Technical Writer for our Amesbury, MA office. This person shall work with our consultants in...

  • Associate Director, Clinical Data Management

    3 months ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    3 months ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Director, RDQA, GCP Operational Quality, CGT

    5 days ago

    Boston, United States Vertex Pharmaceuticals Incorporated Full time

    Director, RDQA, GCP Operational Quality, CGTThe Director of GCP Operational Quality performs advanced GCP quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols and Vertex policies,...

  • Director, RDQA, GCP Operational Quality, CGT

    5 days ago

    Boston, United States Vertex Pharmaceuticals Incorporated Full time

    Director, RDQA, GCP Operational Quality, CGTThe Director of GCP Operational Quality performs advanced GCP quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols and Vertex policies,...

  • Night Warehouse

    4 weeks ago

    Boston, United States Quality Beverage Full time

    Job DescriptionJob DescriptionDescription:Position Overview Quality Beverage is seeking reliable, hardworking employees to work in a fast-paced warehouse environment.Key AccountabilitiesEnsure loads are built to meet standards, loaded accurately, and in a timely manner. Load and unload delivery and over-the-road trucks and ensure proper stock rotation in the...

  • Director Clinical Operations

    2 months ago

    Boston, United States Meet Full time

    Director, Clinical OperationsAn exciting position with an innovative and clinical stage biopharma based in Massachusetts. This company is focused on oncology & have recently received over $100 million in new funding.Job Description:This role is hybrid once a week in Cambridge. . This is a highly visible role, reporting to the CMO, tasked with growing out the...

  • Director Clinical Operations

    2 months ago

    Boston, United States Meet Full time

    Director, Clinical OperationsAn exciting position with an innovative and clinical stage biopharma based in Massachusetts. This company is focused on oncology & have recently received over $100 million in new funding.Job Description:This role is hybrid once a week in Cambridge. . This is a highly visible role, reporting to the CMO, tasked with growing out the...

  • Senior Lead Consultant, Air Quality

    2 months ago

    Boston, United States Ramboll Full time

    Job DescriptionThis position is located at any one of our New England offices in Massachusetts, Maine, or Connecticut.  We are also open to considering qualified candidates to work out of our Blue Bell or Princeton, NJ, or New York office.  Applicants must be currently authorized to work in the United States on a full-time basis. No sponsorship is...

  • Driver (Quality Beverage)

    4 weeks ago

    Boston, United States Quality Beverage Full time

    Job DescriptionJob DescriptionDescription:Position Overview Route Delivery Driver with a CDL license delivers products to businesses on a scheduled route or intermittently. Establish and maintain high levels of customer service. Key AccountabilitiesDrive commercial delivery trucks, vans, and/or tractor-trailer combinations to deliver product to retail...

  • Clinical Social Worker-GIM ED-Addiction Consult Team

    4 weeks ago

    Boston, United States Boston Medical Center Full time

    POSITION SUMMARY: The Integrated Emergency Department Consult Team (ED-ACT) is an interdisciplinary team comprised of addiction attending physicians, advanced practice practitioners, social work staff, and a patient care coordinator. The service provides consultation in the emergency department (ED) for patients with addictions and substance use problems....

  • Manager of Clinical Coding Operations

    2 weeks ago

    Boston, Massachusetts, United States CRICO Full time

    Position Overview:Are you passionate about empowering others to achieve success? If so, we invite you to explore an enriching opportunity with us. CRICO, the medical malpractice insurer for Harvard-affiliated hospitals, is at the forefront of a national medical malpractice data collaborative. We collaborate with various health systems, captive insurers, and...

  • Clinical Specialist

    1 week ago

    Boston, United States Dana-Farber Cancer Institute Full time

    Overview The Clinical Specialist (CS) is a member of the nursing leadership team. The CS influences nurses, nursing support personnel and the organization to support evidence-based practice (EBP) and in collaboration with Dana-Farber Cancer Institute (DFCI) nursing leadership, assures the achievement of quality and cost-effective patient and family outcomes....

  • Clinical Implementation Consultant

    1 week ago

    Boston, Massachusetts, United States EVERSANA Full time

    Job Overview*This is a remote field-based position. Candidates from alternative northeastern cities are encouraged to apply.The Clinical Implementation Consultant (CIC) plays a crucial role in the training and support of healthcare personnel during the introduction of new products. This product launch is part of a broader clinical workflow integration; the...

  • Senior Consultant

    1 week ago

    Boston, United States Lumanity Full time

    Overview / About us Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances. We partner with life sciences companies around the world to generate evidence to demonstrate the value of their product, translate the science and data into compelling product narratives, and enable commercial decisions that...

  • Quality Assurance, Sr. Consultant/Principal

    2 weeks ago

    Boston, United States Slalom Full time

    Business Delivery - Principal, Senior Consultant At Slalom, personal connection meets global scale. Our vision is to enable a world in which everyone loves their work and life. We help organizations of all kinds redefine what's possible, give shape to the future-and get there. Our Business Delivery team is comprised of consultants with the expertise to...

  • Quality Assurance, Sr. Consultant/Principal

    2 weeks ago

    Boston, United States Slalom Full time

    Business Delivery - Principal, Senior Consultant At Slalom, personal connection meets global scale. Our vision is to enable a world in which everyone loves their work and life. We help organizations of all kinds redefine what's possible, give shape to the future-and get there. Our Business Delivery team is comprised of consultants with the expertise to...

  • Senior Lead Consultant, Air Quality

    1 week ago

    Boston, United States Ramboll Full time

    Job DescriptionThis position is located at any one of our New England offices in Massachusetts, Maine, or Connecticut.  We are also open to considering qualified candidates to work out of our Blue Bell or Princeton, NJ, or New York office.  Applicants must be currently authorized to work in the United States on a full-time basis. No sponsorship is...

  • Process Engineer, Clinical Operations

    1 month ago

    Boston, United States Elucid Full time

    We are a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs. Come work at Elucid and be part of delivering on our mission to prevent heart attacks and strokes.Are you passionate...

  • Process Engineer, Clinical Operations

    1 month ago

    Boston, United States Elucid Full time

    We are a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs. Come work at Elucid and be part of delivering on our mission to prevent heart attacks and strokes.Are you passionate...