About this role
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