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:
1. Lead and coordinate the execution of clinical trials across country/region for high priority and complex trials
2. Leverage deep expertise in regional trial execution to support Trial Capabilities representation in global, cross functional clinical trial forums
3. Anticipate and mitigate risks and resolve complex and critical risks/issues to enable timely delivery of Trial Capabilities commitments across countries/region
4. Influence execution based on knowledge of regulations and applying the learnings from regulatory/ERB feedback gained from other programs
5. 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
6. 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
7. 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
8. 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
9. 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
10. Lead and consult on internal audits and external inspections as well as supporting institutions/investigative sites in inspection readiness initiatives
Requirements:
11. Bachelor's degree preferably in a scientific or health related field, six years clinical research experience or relevant experience preferred
12. Understanding of the overall clinical development paradigm and the importance of efficient site initiation
13. Previous supervisory experience
14. Strong leadership skills and ability to influence others and lead across the business
15. Project management processes and skills
16. Appreciation of / experience in compliance-driven environment
17. Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
18. Effective communication, negotiation, and problem-solving skills
19. Self-management and organizational skills