Implements CPTS Tactics that Drive for Impact: As a key member of the CPTS and country clinical operations teams, delivers CPTS activities related to GCP compliance, process, systems and training support to ensure the country clinical operations teams meet current and future business needs and study goals:
Responsible for making decisions around CPTS deliverables and empowered to take ownership to drive impactful results Locally delivers CPTS tactics that enables clinical operations to achieve GCP Inspection Readiness status in alignment with global and regional plans/goals. Embeds a continuous improvement culture in clinical operations in the country Facilitates cross-country alignment, information sharing and best practices within the regional CPTS team, driving local and regional efficiency Builds influential partnerships with key internal and external local and regional stakeholders to ensure that country clinical operations business needs are met and identified risks/issues are swiftly and effectively managed by accountable functions (e.g. SPE, SQT2, PDQ, IQVIA, Medical Affairs) Anticipates the needs of country clinical operations teams and implements changes in strategy or tactics when needed to improve the effectiveness of CPTS Provides GCP, process, systems and training expertise for functional improvement initiatives. May lead or provide subject matter expertise to continuous improvement initiatives.
Operational Support: Drive improvements in the local implementation of GCP excellence, systems/process and training support to country clinical operations and to the wider regional affiliate network (as appropriate). Working in close collaboration with regional and global teams to ensure that systems/process and training is effective and fit for purpose for local clinical operations teams, ensuring compliance to local laws and regulations.
Identifies and escalates via established networks local needs that may require global solutions to enable Inspection Readiness. Development and maintenance of local CPTS business processes for local clinical operations, partnering with GPOs and functional BPOS where appropriate In close collaboration with global and regional teams (e.g. SPE, SQT2 and PDMA) delivery of CPTS process, systems and training support. May act as a local or regional subject matter expert (SPOC) for a specific focus area e.g. GCP, systems, process or training Provides local support for audits and inspections related to clinical operations, country and investigator site management Provides GCP subject matter expertise, working in collaboration with clinical operations teams to identify and effectively manage GCP related risks and issues. Partners with clinical operations teams to ensures adherence to key processes, systems and initiatives in the Country to ensure inspection readiness Share local business insights 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 implement effective actions to mitigate risks and ensure inspection readiness May play a role within the oversight of the FSP, responsible for proactively identifying, managing and, where appropriate, escalating risks and issues related to GCP compliance, process, system and training. May participate as an active member of the Local Medical Compliance governance model (if applicable), representing the GCP pillar, as needed and provides input into medical compliance risks and issues related to compliance, process, systems and training. Work closely with the regional CPTS team enabling CCO to operationalize new process, initiatives and drive continuous improvement f Has an awareness of, and manages ongoing changes to regulations, guidelines, ICH-GCP standards and global processes Collaborates with key stakeholders and managers, as applicable, to ensure that all staff are appropriately trained and supported regarding the Roche global and local procedures and systems. Ensures CAPAs derived from Audits and Inspection reports for GCP related findings are effectively implemented, in order to mitigate impact in key high risk areas and best practices are shared across the affiliate and/or sub-region Proactively identifies, and in collaboration with global and regional teams, implements improvements to systems, process, training or tools to achieve quality standards and efficiencies
Experience, Skills, Knowledge Required
- Bachelor degree (or equivalent} in a science discipline
- Experience working in clinical operations management in a drug development setting
- Effective leadership, influencing skills and teamwork supporting an environment of mutual respect, embracing change, innovation and accountability at all levels
- Ability 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
- Expert knowledge of ICH GCP and local regulatory requirements.
- Skilled in 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
- Planning and organizing
- Facilitating change
- Building partnership
- Building customer loyalty and service delivery
- Decision making
Availability to travel internationally.