Associate Director Clinical Trial Capabilities
Our client, a global pharmaceutical organization, is recruiting an Associate Director to lead the Clinical Trials Capabilities team on a permanent basis. This role will provide leadership, direction, and technical support to clinical trial teams, focusing on results and driving efficiency to achieve goals and objectives.
Key Responsibilities:
* Lead and coordinate the execution of clinical trials across countries/regions 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 issues to enable timely delivery of trial capabilities commitments across countries/regions.
* Influence execution based on knowledge of regulations and apply learnings from regulatory/ERB feedback gained from other programs.
* Support implementation and drive compliance to value-added projects, such as Vault Clinical Study Start-Up (SSU), electronic Trial Master File (eTMF), and 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 enrollment readiness.
* Contribute scientific and disease expertise and utilize strategic knowledge of the organization'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 of 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.