External Operations Manager

Major responsibilities:

Your responsibilities include, but are not limited to:

• Build the interface between the clinical supply chain functions, clinical teams, and the external partner with defined governance meetings (CTT Sub team, Vendor Operational Control Tower)
• Lead finance activities, Purchase Orders (PO), invoice approval and tracking financial metrics.
• Liaise with Comparator Sourcing Supply Lead, Study Lead and internal GCS study team (with Clinical Trial Supply Manager and Comparator Sourcing Supply Lead) on a regular basis to support accurate study protocol interpretation, provide guidance for correct demand calculation and to ensure operational responsiveness to study dynamics.
• Ensure most cost-efficient material flow, minimizing waste and allowing the flexibility to accommodate the changing demand.
• Monitor vendor performance with pre-defined KPIs and collaborate with vendor to identify process optimizations and ensure follow up and completion of actions.
• Support the collection, analysis, interpretation, cleansing and exchange of site demand, stock and enrollment data in close collaboration with the CTSM and the CMOs clinical supply optimization team
• Ensure automated key portfolio data are available, accessible and timely for external partners to operate
• Coordinate and actively monitor site (re)-supply for defined high priority trials and materials.
• Support and guide the external partner in the development, maintenance, and execution of an optimal resupply strategy, in the proactive planning of site stock replenishment and the proactive expiry management, to ensure compliance and continuity of clinical supplies.
• Own, monitor and act on operational KPIs together with the external partner.
• Be the main interface between external partner functions and internal collaborators (GCO, Regulatory, CTA Hub, Quality Assurance, Qualified Person).
• Identify, assess, and proactively communicate supply risks to all relevant partners along with appropriate mitigation strategies to ensure supply continuity.
• Retrieve and communicate relevant changes in the study design, timelines, country footprint and co-ordinate the implementation with the external partner.
• Work closely with the vendors and clinical team, regulatory, and supply chain teams to ensure that the  product sourcing strategy is implemented according to the set trial timelines and regulatory requirements.
• In collaboration with the external partners work towards standard processes and optimization of comparator demand and supply planning processes.

Essential Requirements:

• Degree in science, engineering or equivalent.
• >5 years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise
• Good knowledge about the Drug Development and study demand planning process
• Basic project management, good organization and planning skills
• Knowledge of Good Manufacturing Practices and Health, Safety & Environment (GMP & HSE) regulations.
• Very good communication, Fundamental Leadership, negotiation and interpersonal skills and the ability to work in interdisciplinary teams.

Desirable Requirements:

• Distribution experience in Pharma