Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track. Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring)
Verifies and provides input into the country allocation and oversees trial feasibility
Accountable for development and implementation of trial level engagement plans, recruitment planning and risk mitigation
Leads development of core trial and patient facing documents
Integrates patient/site level feedback during document development and ensures trials are designed with a focus on patient value
Ensures activities are frontloaded where possible at the trial level and cascaded to country level to facilitate efficiencies as well as to ensure and leverage speed
Oversees outsourcing of vendor services in conjunction with other functions; supports identification of vendors, vendor selection and development of vendor scope of work
Works with functional partners to ensure that all required trial processes are in place to meet trial delivery milestones (e.g. clinical quality monitoring, safety monitoring and reporting, investigational medicinal product, trial budget, site monitoring)
Aligns and supports team members in timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders
Provides/supports provision of appropriate study- specific and standardized non-trial specific trial team training, internal and external partners
Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation
In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, Safety Management Committee (SMC)/Data Management Committee (DMC) management and safety reporting
Prepare and implement amendments of core documents including training material updates/retraining as needed
Support authority/ethics responses to requests as applicable
Maintains oversight of outsourcing of vendor services (including central lab) in conjunction with other functions
Monitor progress of patient recruitment and accrual of endpoints and proactively update and action contingencies throughout trial conduct.
For early clinical trials, co-ordinates and harmonizes Innovation Unit tasks in a trial (e.g. biomarker sampling, genomics, sub-studies)
Strong clinical trial project management experience. In-depth understanding of project management with emphasis on team work to promote high-performance teams
Experience in Therapeutic Areas relevant in client pipeline is desirable
Understanding of major regulations (US FDA, EMA and PMDA)
Familiarity with guidelines and standard of care is desirable
Cross geographical experience. Working in multi-cultural environment; strong understanding of corporate culture and cross-cultural dynamics
Strengths in mentoring/coaching
Demonstrated competencies in Agility, Accountability, and Intrapreneurship: fast decision-making, flexibility, ownership, outcome-based thinking, results orientation, and smart risk-taking
Strong Communication Skills: Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Demonstrates active listening skills and cultural awareness.
Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all aspects of clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors. Extensive experience in clinical trial project management in an international context.
Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations, confidently setting direction for teams. Demonstrates leadership behaviors of supporting, connecting, and empowering teams, providing future direction, demonstrating visionary and innovative thinking and inspiring teams to achieve a common goal. Executes activities with a clear aim to deliver value to patients.
Strategic Mindset: Strategic and visionary thinker who is future focused, creative, courageous, and able to navigate through ambiguity. Integrates study strategy with overall TA portfolio. Embraces cross functional initiatives, applying innovative learnings. Is results-oriented with a global mindset using analytical thinking to provide risk-balanced solutions.
Coordination and Oversight: Collaborative leader who demonstrates skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources.
Project Management: Plans effectively, setting priorities, and defining actions. Makes effective use of resources, and proactively strives for transparency and clarity to accomplish the business deliverables. Translates complex situations to actionable parts. Anticipates and resolves challenges and translates learnings to new projects. Takes smart risks.
