The Compliance Process, Training and Systems (CPTS) team within CCO provide clinical trial GCP expertise, process/systems and training support across CCO and to clinical operations staff in the wider affiliate network, in close collaboration with other global functions (e.g. MCO, SPE, QT2, PDMA, PDQ).
The role of the Regional Leader, Compliance, Process, Training and Systems (RL-CPTS) is to provide regional input into the strategic global direction and drive the implementation of the global strategy through strong leadership and direction to the regional CPTS team. A core member of the CPTS Global Leadership team, the CCO Regional Leadership team and the Regional Medical Compliance governance model (RMCO), proactively driving the delivery of CPTS activities that ensures that regional/local processes, systems and training enable efficient and GCP compliant clinical trial delivery. Ensuring that current and future business objectives (e.g. LSPC and study goals) are met.
Establishes effective regional and global partnerships to ensure the needs of CCO are met (e.g SQT2, SPE, IQVIA, PDQ, PDMA, IQM etc.). Drives the regional implementation of the CPTS strategy and tactics which allows the proactive identification and effective management of clinical trial GCP compliance, process, systems and training related risks, issues and inefficiencies. Driving a culture of GCP compliance and continuous improvement across CCO and, where appropriate, clinical operations in the wider affiliate network.
Main Accountabilities and Responsibilities
Strategic Direction Setting and Driving for Impact: As a key member of the global CPTS and Regional CCO leadership team, drives the implementation of the CPTS Strategic Plan related to GCP and compliance, process, systems and training to ensure CCO meets current and future business needs and study goals:
1. Provides regional Leadership & Strategic Direction to ensure the CPTS strategic plan related to GCP compliance, process, systems and training is implemented in the region to enable CCO to meet current and future business needs. Manages the implementation of the strategic direction.
2. Drives the CPTS strategy that enables clinical operations to achieve GCP Inspection Readiness status in alignment with global and regional plans/goals
3. Shares the vision and inspires the CPTS team to make decisions, take ownership and drive cross functional teamwork to achieve impactful results
4. Embeds a continuous improvement culture in clinical operations across the regions
5. Monitors the productivity and efficiency of the I CPTS team in collaboration with the Regional Head and Country Heads. Drives the alignment of local, regional and global priorities
6. Provides the regional CPTS budget forecasting and resource plans to the Regional Head
7. Facilitates cross-regional alignment, information sharing and best practices within the global CPTS leadership team, driving global efficiency
8. Builds influential strategic partnerships with key internal and external regional stakeholders to ensure that CCO business needs are met and identified risks/issues are swiftly and effectively managed by accountable functions (e.g. SPE, SQT2, PDQ, IQVIA)
9. Continually assess the business impact of CPTS tactics/activities, provide regional direction when changes in strategy or tactics are needed to improve the effectiveness of CPTS
10. Provides GCP, process, systems and training expertise and leadership for CCO for functional improvement initiatives. May sponsor or be a business lead for portfolio enabling projects
Operational Support: Drive improvements in the regional implementation of GCP excellence, systems/process support and training to CCO and to clinical operations in the wider affiliate network, as appropriate.
1. Work closely with the global CPTS team enabling CCO to operationalize new process, initiatives and drive continuous improvement
2. Accountable for the development and maintenance of CPTS business processes for local I regional clinical operations. Partnering with Global Process Owners and functional Business Process Owners, where appropriate
3. Accountable for the delivery of local I regional CPTS process, systems and training support. Working in close collaboration with global teams (e.g. SPE, SQT2 and PDMA) to ensure global solutions are fit for purpose for country clinical operations teams. May act as a local or regional subject matter expert for a specific focus area e.g. GCP, systems, process or training
4. Drives local CPTS support for audits and inspections related to clinical operations, country and investigators site management
5. Deliver business insights to regional teams and quality management tactics by utilizing multiple sources of information to identify trends and risk (e.g. system reports, help desk data, inspection reports, audit findings, CAPAs and internal/external benchmarking data) to drive appropriate discussions and implementation of actions to mitigate risks
6. Actively partner with RMCO/PDG to ensure delivery on quality objectives, QMS plans and risk management activities to ensure GCP excellence for clinical trials in CCO and clinical operations in the wider affiliate network
7. Actively represents the global/regional/local needs of CCO within PDG (e.g. SPE, SQT2) and with other internal partners (e.g. IQM, PDMA) driving the proactive identification and effective management of clinical trial GCP compliance, process, systems and training related risks, issues and inefficiencies
8. Strategic member of the FSP Regional Operating Committee accountable for proactively identifying risks and issues related to GCP compliance, process, systems and training. Driving mitigation and corrective action plans across the regional governance team to ensure inspection readiness
9. Ensures the Regional CPTS/GCP Network members are aware and manage ongoing changes to regulations, guidelines, ICH-GCP standards and global processes
Leads and drives cross functional teams in order to achieve impactful results Line Management: Lead a highly motivated CPTS team through outstanding leadership, coaching and people management, ensuring an objective and performance-led management culture and providing excellent career development pathways.
1. Direct management of a team of CPTS employees including resource management, performance and compensation management and individual development planning
2. Set a culture and strategy that ensures appropriate performance management and career development of CPTS team
3. Actively manage the performance calibration, talent management, and succession planning of the CPTS team
4. Ensure the CPTS staff meets their training obligations to maximize their contribution and ensure adherence to regulatory standards and mandatory company procedural documents (i.e. SOPs and Policies)
Experience, Skills, Knowledge Required
• Bachelor degree (or equivalent) in a science discipline; advanced degree preferred
• Considerable experience working in clinical operations management in a drug development setting
• Highly effective leadership, influencing skills, ideally across a number of different locations, cultures, with the ability to create a positive work environment characterized by teamwork, mutual respect, embracing change, innovation and accountability at all levels
• Demonstrated skills in persuading senior leadership on strategy, initiative implementation and decision-making. Influences and motivates others to achieve objectives.
• Ability to prioritise multiple, conflicting priorities and drive teams to deliver impactful and effective solutions/outputs
• A clear understanding of GCP and compliance process, activities and issues and the ability to develop, manage, and improve compliance activities across a diverse area of activity and wide geographic spread including the ability to operate objectively and independently
• Skilled in providing direction setting milestones, driving toward and monitoring results
• Self-motivated and achievement driven with ability to work independently, be attentive to detail, and act with a sense of urgency
• Strong written and verbal communication skills to a variety of levels and teams.
• Demonstrated ability to meet customer needs in the most cost-effective manner without sacrificing quality
• Strategic Influence
• Driving for Results
• Building Partnerships
• Leading Change
• Customer Focus
• Delegation & Empowerment
• Frequent international travel will be required at times. The amount may vary with the role, location and business circumstances
• Works globally, regionally and across cultures