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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Associate Director Clinical Trial Capabilities


Reference:SCA012235 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Trials Advisor

Associate Director Clinical Trial Capabilities
Our client, a global pharmaceutical organisation are currently recruiting an Associate Director to join their Clinical Trials Capabilities team on a permanent basis. As Associate Director you will lead the clinical trial capabilities in support of clinical development. This is an exciting opportunity which will allow you to provide leadership, direction and technical support to the Clinical Trial Capabilities Teams focusing on results and driving efficiency to achieve goals and objectives

Responsibilities:

  • Lead and coordinate the execution of clinical trials across country/region for high priority and complex trials
  • Leverage deep expertise in regional trial execution to support Trial Capabilities representation in global, cross functional clinical trial forums
  • Anticipate and mitigate risks and resolve complex and critical risks/issues to enable timely delivery of Trial Capabilities commitments across countries/region
  • Influence execution based on knowledge of regulations and applying the learnings from regulatory/ERB feedback gained from other programs
  • 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
  • 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
  • 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
  • Contribute scientific and disease expertise and utilize strategic knowledge of the organisation’s portfolio and priorities to lead country prioritization of work and anticipate future needs for Trial Capabilities
  • 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
  • Lead and consult on internal audits and external inspections as well as supporting institutions/investigative sites in inspection readiness initiatives

Requirements:
  • Bachelor’s degree preferably in a scientific or health related field, six years clinical research experience or relevant experience preferred
  • Understanding of the overall clinical development paradigm and the importance of efficient site initiation
  • Previous supervisory experience
  • Strong leadership skills and ability to influence others and lead across the business
  • Project management processes and skills
  • Appreciation of / experience in compliance-driven environment
  • Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
  • Effective communication, negotiation, and problem-solving skills
  • Self-management and organizational skills
For more information please contact Sinéad Cullen on +353879500821 or [email protected]