- Entry level
- No Education
- Salary to negotiate
Advisor - Compliance Process, Training & Systems, Country Clinical Operations
Function: Pharma Development Operations
Department: Country Clinical Operations
Location: PDG Integrated Affiliate
Local Reporting Line: Manager CPTS
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 collaboration with other global functions (e.g. SPE, SQT2, PDMA, PDQ).
The role of the CPTS Advisor is to implement the local CPTS strategy in line with the global CPTS direction and to provide GCP expertise to country clinical operations teams. A key member of the local and regional hub (where applicable) CPTS team, responsible for delivering CPTS tactics that ensure the delivery of fit for purpose processes, systems and training support to clinical operations, enabling efficient and GCP compliant clinical trial delivery. Ensuring business objectives (e.g. LSPC and study goals) are met.
Establishes effective local and regional partnerships (e.g FSP Partners, LQR, Medical Affairs, etc.) to ensure the needs of their clinical operations teams are met. Proactive identification and effective management of clinical trial GCP compliance, process, systems and training related risks, issues and inefficiencies. Embeds a culture of GCP compliance and continuous improvement in their country and, where appropriate, the wider regional affiliate group through the country hub structures.
Main Accountabilities and Responsibilities
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 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) 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 and occasionally conducts audits and inspections related to clinical operations, country and investigator site management Partners with clinical operations teams to ensures adherence to key processes, systems and initiatives in the Country to ensure inspection readiness Has an awareness of, and manages ongoing changes to regulations, guidelines, ICH-GCP standards and global processes 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
Experience, Skills, Knowledge Required
Bachelor degree (or equivalent) in a science discipline
Experience working in clinical operations management in a drug development setting
About the company
Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.
The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.