Associate Director of Trial Capabilities
Bespoke Recruitment
Associate Director – Trial Capabilities
Cork, Ireland (hybrid)
Responsibilities:
Lead and share technical and operational expertise across the Global Trial Capabilities organisation (>400 people) as well as across Clinical Design, Delivery and Analytics (CDDA).
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Lead and coordinate the execution of clinical trials across the country/region for high-priority and complex trials representing geographical complexity.
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Leverage deep expertise in regional trial execution to support Trial Capabilities representation in global, cross-functional clinical trial forums.
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Anticipate and mitigate risks and resolve complex and critical risks/issues to enable timely delivery of Trial Capabilities commitments across countries/region.
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Influence execution based on knowledge of regulations and applying the learnings from regulatory/ERB feedback gained from other programs. Recognized as a leader representing Trial Capabilities for the countries of responsibility and the region.
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Support implementation and drive compliance to value added projects e.g., Vault Clinical Study Start-Up (SSU), electronic Trial Master File (eTMF), Shared Investigator Platform (SIP) to ensure impactful portfolio support and management.
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Lead and support global functional projects related to integration of processes and automation to drive global solutions across geographic regions partnering with Trial Capabilities Leadership and global clinical system and information technology functions.
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Provide input into the design and implementation of value-added solutions that will enhance Trial Capabilities effectiveness and productivity and enable acceleration of enrolment readiness.
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Contribute scientific and disease expertise and utilize strategic knowledge of the portfolio and priorities to lead country prioritization of work and anticipate future needs for Trial Capabilities.
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Recognized as an expert in local/global regulations, laws, and guidance (e.g., ICH), and assess the impact on local and global processes ensuring internal processes and procedures reflect and comply with country requirements.
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Lead and consult on internal audits and external inspections as well as supporting institutions/investigative sites in inspection readiness initiatives.
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Drive and/or support discussions with regulatory bodies / ERBs providing rational for specific protocol elements and ICF language.
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Engage with regulatory bodies and ERB to influence and challenge internal and external factors shaping clinical trial execution e.g., Decentralized Trial model and trial mitigations impacted by unforeseen circumstances.
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Lead Trial Capabilities team to effectively manage study start-up.
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Proactively identify process improvement opportunities and collaborate with the CDDA functions to re-design more effective and efficient processes including building clear accountabilities and responsibilities for vendors to ensure optimized delivery at country/region and global level.
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Identify and develop robust mechanisms to retain a scientific, technical, and operationally capable Trial Capabilities workforce skilled and knowledgeable in clinical development.
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Effectively manage an agile organization that continuously meets the needs of a changing portfolio.
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Acts as a subject matter expert coaching and mentoring individuals within Trial Capabilities and CDDA organization.
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Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment-based decision making in clinical delivery.
Requirements:
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Bachelor’s degree preferably in a scientific or health related field.
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At least 6 years clinical trial experience or relevant experience preferred.
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Deep therapeutic expertise and knowledge of clinical research.
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Proficiency in country/regional regulatory guidelines/requirements.
