Clinical Program Quality Excellence Lead - FSP Team

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