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Contact Info
Alan O'Riordan
Life Science

+353873657522
[email protected]
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Details

Associate Director- Clinical Trial Capabilities Lead


Reference:AOORAMKY-785368 Location: Cork
Cork City
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Associate Director- Clinical Trial Capabilities Lead (Systems & Technology)



Purpose
Associate Director- Clinical Trial Capabilities Lead (Systems & Technology) S&T drive implementation of and compliance with capabilities including Vault Clinical platform, SIP and other clinical trial support technology and automation efforts to enhance Trial Capabilities operational visibility, control, compliance and oversight of business activities (including submission and clinical trial application strategy, site budget and contracting, clinical finance and payment, trial records management, trial training, and trial metrics across all therapeutic areas) to enable end to end Trial Capabilities delivery.
  • The Associate Director (ST) represents the TC region interests by collaborating with and influencing partner functions (e.g CSP, CD, IT etc) supporting delivery of new capabilities that match needs of the wider CDDA and/or TC function as well as supporting Investigator sites in providing efficiency and effectiveness gains.
  • The Associate Director (ST) collaborates on and identifies new opportunities to leverage for the region and is responsible for the strategic planning and operational execution of those adopted
  • The Associate Director (ST) will work with existing SME’s within the region and globally in TC supporting our investments
  • The Associate Director (ST) will ensure inspection readiness at all times by following GCP; any local/regional requirements and Lilly operating procedures.
General Expectations
  • Use project management skills, processes, and tools to develop and execute local, regional, and/or global implementation projects. Monitor the status and make adjustments and changes as needed to meet the deliverables of solutions.
  • Risk - Assess, identify and monitor counter actions and utilise regional expertise to invoke mitigation and contingency plans working with TC leaders
  • Lead, influence and project manage large, complex OCM programs for new technology capabilities and/or enhancing existing technology capabilities in Trial Capabilities
  • Independently drive and influence local, regional and global, cross-functional teams from concept to implementation representing the Trial Capabilities needs
  • Foster relationships and serve as a single point of contact and central owner for communication, to and from delivery functions and vendors. Effectively manage and influence upward.
  • Anticipate and resolve complex and key technical operational or business problems with cross-functional partners including TP vendors, Evaluate and determine issues that require escalation.
  • Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, or geographical
  • Leverage expertise to make timely decisions for ambiguous and complex situations and uphold a consistent, solution-oriented approach to conducting daily business.
  • Demonstrate credibility and influence to enable teams and multiple business partners, both internally and externally, to make effective and timely decisions.
  • Recognize inter-dependence of technology solutions on business deliverables within the portfolio and understand the impact of project decisions on the overall portfolio in Trial Capabilities.
  • Apply knowledge of the regional operating model; coordinate and facilitate obtaining regional input to inform decision making
  • Ensure solutions facilitate inspection readiness of the respective clinical trial portfolio
  • Identify and lead process improvement activities. Acts as a CTPM SME resource to peers and in the development and rollout of new tools, processes or methodologies to proceed as quickly as the science allows.
  • Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials. Liaise with regional SME’s and other appropriate resources to understand local regulatory requirements.
  • Independently detect and resolve quality issues, escalating to functional leadership or consulting other functions (e.g., Medical Quality, Legal, Compliance, etc.) to arrive at the best solution.
Minimum Qualifications
  • Bachelor’s degree preferably in a scientific or health related field
  • At least five (5) years clinical trial experience or relevant experience preferred

For further information, contact Alan on [email protected] / +353 87 365 7522