Associate Director, Regional Delivery Lead, Europe

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Position Summary

The Associate Director, Regional Delivery Lead (RDL) is a project leader that helps drive accountability and delivery of all country clinical operations team commitments within a region (e.g., Americas, EMEA, APAC, etc.) for assigned trials throughout the end-to-end study lifecycle by coordinating between global and local teams. The RDL directly works with Global Trial Managers, Clinical Trial Managers and Regional Clinical Operations country leadership in countries within their region to support delivery of multiple trials. The Associate Director, Regional Delivery Lead is someone who is passionate for coordination, experienced in country/regional clinical trial delivery, able to implement strategic solutions and demonstrates strong communication and leadership skills.

• Drives the clinical trial feasibility process and decision-making for country, site, and patient allocations on behalf of a region in collaboration with global and country operational leaders
• Monitors and drives country-level timeline planning and sequencing of events in assigned region during study start-up within a region
• Synthesizes learnings from trends surfaced from regional monitoring throughout study conduct and leads patient re-allocation decisions as needed

Key Responsibilities

Feasibility

• Leads decision making for allocation of countries, sites and patients for insourced clinical trials in collaboration with global and country study leadership
• Drives the country- and site-feasibility processes within assigned regions
• Communicates country perspectives on study feasibility to facilitate effective planning and assumptions when establishing milestones for a trial
• Monitors country progress during feasibility and escalates concerns to the global team
• Ensures that relevant stakeholders are proactively notified of key feasibility decisions

Study Start-up

• Oversees country-level timeline planning and drives inputs for the global team to holistically sequence events; ensures adherence to timelines and pushes teams towards mass site activation
• Synthesizes regional challenges and shares with global study team for early mitigation; pressure tests mitigation strategies to be employed to overcome challenges
• Oversees regional progress towards delivery of key documents for regulatory/HA submission, and communicates delays across stakeholders
• Communicates bi-directionally between global and local stakeholders to support clinical trial delivery
• Coordinates and tracks progress towards site activation goals including clearing bottlenecks and flagging delays at a regional level
• Drives local accountability and momentum towards key milestones

Study Conduct

• Monitors country and  regional trends in enrollment and execution; Synthesizes trends and patterns for leadership consumption
• Monitors patient enrollment across countries to identify regional patterns and inform global study team when reallocation is warranted
• Ensures proper oversight and accountability on key data metrics through database lock
• Performs country-level storyboarding

Relationship Management

• Proactively develops and maintains collaborative relationships with global and local stakeholders on multidisciplinary teams across leadership levels within the organization
• Ensures appropriate methods are used when communicating with key stakeholders and cross-functional partners

Leadership and Decision Making

• Effectively influences and communicates with individuals at all lev