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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Director Clinical Trials


Reference:SCAWKX-016780 Location: Cork
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Senior Director Clinical Trials
Our client, a global pharma company are currently recruiting for a Senior Director to join their Trial Capabilities team on a permanent basis. As Senior Director Trial Capabilities you will support strategy, oversight and expertise for the Trial Capabilities processes involved in site activation/management/closeout, clinical finance, records management and site contracting.

Responsibilities

  • Accountable for leading transformational initiatives around key business processes and tools for Trial Capabilities setting the continuous improvement strategy for the end-to-end processes across all regions
  • Challenge, modernize and streamline existing process within the function as well as integration of process that has an impact on portfolio delivery
  • Provides strategy, oversight and expertise in site activation enabling innovative approaches to continue to drive increased efficiencies and ways to measure effectiveness
  • Partner with Clinical development functional leadership to evaluate, provide clear business requirements and determine implementation of any new technology to enable automation of processes
  • Lead and support functional projects and integration of processes with other functions driving global solutions across geographic regions
  • Engage in coaching and training to ensure effective implementation of processes and solutions
  • Accountable for understanding and managing risks associated with strategic initiatives and engaging proactively with Clinical development leadership to resolve and manage potential risks
  • Engage effectively with the external environment to ensure a continued state of awareness of applicable country requirements and trends including new ways of conducting clinical research e.g Decentralized Trials, Master Protocols etc
  • Lead the assessment of regulatory requirements in applicable countries and ensuring requirements are incorporated into global procedures or business processes, as appropriate, actively considering implication on resources.
  • Interact, educate, facilitate and influence tactics and strategy working with Clinical development functional leaders and other relevant functions and affiliates to ensure business requirements are met as well as evolving regulatory requirements
Requirements
  • Advanced degree in scientific related fields and at least 10 years’ experience in Clinical Development
  • Process management experience and preferably project management skills
  • Deep technical expertise translated into strong knowledge in site activation processes and regulatory requirements
  • Proven ability to assess new information or issues and adjust course without jeopardizing overall project goals
  • Ability to interpret and apply regulatory requirements into business processes
  • Recognized as an expert in business processes related to clinical development
  • Strong communication skills and demonstrated ability to communicate clear goals and measures at several levels of the organization and negotiate across multiple groups
  • Strong leadership and interpersonal skills, ability to influence across multiple functions and regions and able to work independently and as team members on variety of topics/issues
  • Ability to work in a global environment
  • Strong problem-solving skills: able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent recurrence within the team
  • Excellent self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
  • Flexibility to adjust quickly and effectively to frequent change and altered priorities
For more information please contact Sinéad Cullen on +353879500821 or [email protected]