Clinical Program Quality Excellence Lead - FSP Team

Location: Remote, North Carolina, United States of America

Category: Quality & Regulatory

Employment Type: Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

OBJECTIVES/PURPOSE

• Facilitate and manage cross-functional teams’ GCP inspection readiness and execution activities throughout the study lifecycle
• Embed real-time inspection readiness strategies into daily operations in collaboration with study teams, aligned with Global Development Compliance and Clinical Quality Assurance.
• Ensure high-quality deliverables for global studies or programs by guiding study teams on adherence to operational processes and well-prepared documentation
• Champion proactive and continuous prioritization of inspection readiness, focusing on key study operational processes and GCP process excellence, including TMF quality strategies, study-level risk assessments and actioning compliance monitoring signals

ACCOUNTABILITIES

• Provide just-in-time guidance to study teams on key operating model processes and required documentation, prioritizing real-time inspection readiness
• Manage and guide teams on inspection readiness planning, including developing and maintaining inspection readiness plans and tools in collaboration with cQA and GCP Excellence in Clinical Trials leadership.
• Facilitate development of key inspection deliverables including but not limited to required listings, functional presentations, issue related storyboard development, and study team preparation for audits and inspections
• Action compliance monitoring signals and study health metrics with teams to mitigate real-time issues
• Engage appropriate Sponsor and CRO SMEs in inspection readiness activities and study-level risk assessment investigations
• Oversee and manage overall TMF performance and processes, including risk-based oversight strategies and adherence to TMF Plan and TMF Index, to ensure compliance and inspection readiness, including the cross-functional study team and outsourced elements to the CRO.
• Lead and participate in Strategy Team Meetings and Lead Core Team Meetings for assigned projects
• Ensure effective communication and issue escalation internally and externally with vendors
• Maintain project management documentation such as plans, timelines, and progress reports for ongoing inspection readiness
• Coordinate key activities to enable study team readiness for internal study audits and regulatory inspections, including management of required listings and study team preparedness
• Manage functional teams during inspections, collaborate with SMEs, provide follow-up, and ensure timely fulfillment of requests and responses.
• Facilitate and monitor study-specific CAPA related activities in collaboration with GCP Compliance Management and QA
• Identify and implement improvements in inspection readiness and study execution processes.
• Provide regular status updates to stakeholders and leadership.
• Ensure alignment with functional SMEs and cQA in real time throughout study lifecycle and during audits and inspections.

Technical/Functional (Line) Expertise

• Comprehensive understanding of the pharmaceutical industry (e.g., clinical development, operating models, the prescription drug distribution process, etc)
• Effective project management leader
• Advanced expertise in GCP, ICH and applicable global and local regulatory standards governing clinical research
• Advanced expertise in complex Trial Master File deliverables, TMF structures and electronic document management systems (ie.CTMS, SSU, eTMF), Veeva preferred
• Strong ability to learn new systems and technology quickly and provide training to cross-functional study teams
• Demonstrated abiltity to monitor, interpret and action key performance metrics including study compliance and TMF health data

Leadership

• Demonstrated ability to work across functions, regions and cultures
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
• Proven skills as an effective team player who can influence stakeholders, engender credibility and confidence within the company
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
• Navigation of changing priorities and communication managment
• Managing deliverables; demonstrating the ability to lead others to drive deliverables forward

Decision-making and Autonomy

• Accountable for implementing resourceful and effective strategies for cross functional team performance; ability to make independent decisions for designated function; escalation of issues as needed.
• Ability to work in a fast-paced environment with demonstrated ability to manage mulitple competing tasks and demands.
• Ability to work with timelines and complete tasks according to deadline.

Interaction

• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
• Effectively resolve conflict in a constructive manner
• Ability to collaborate effectively with internal and external study team including vendors as needed

Innovation

• Ability to take risks implementing innovative solutions; comfortable with flexibility to adapt to changing environment.
• Applies lessons learned to continuous improvement of GCP excellence, training and documentation management practices across study teams

Complexity

• Ability to work in a global ecosystem (internal)
• Requires strong attention to detail in oversight and completion of competing delivarables
• Ability to take ownership and manage tasks, as well as communicate effectively, establishing priorirties, scheduling and monitoring deadlines for multiple complex studies or programs

 

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field
• Solid knowledge of and experience in GCP compliance, regulatory inspection readiness and study execution processes
• Experience with CROs and outsourced clinical trial activities, sponsor experience preferred
• Solid knowledge of drug development and clinical trial processes, including related standards and documents.
• Experience in clinical trials systems management and oversight (Veeva preferred)
• Proven awareness of sponsor oversight requirements and regulations
• Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
• Strong project management and communications skills to effectively assess risks, establish priorities, take initiative, and meet deadlines
• Must be able to work in a fast-paced, changing environment with demonstrated ability to prioritize multiple competing tasks and demands
• Solid knowledge of regulatory requirements governing clinical trials and industry best practices
• Bachelor’s degree preferred or commensurate with experience
• Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations