Associate Director / Director Global Clinical Process Management Lead

About the role

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director / Director Global Clinical Process Management Lead based in United States. As a Global Clinical Process Management Lead, you will drive efficient, consistent, sustainable, and compliant clinical processes across global clinical operations. You will serve as a key point of contact for critical processes, procedural documents, standards, and continuous improvement initiatives. The role combines process design, technical writing, change management, compliance, and cross-functional collaboration in a global environment. You will work with process owners and subject matter experts to develop and implement high-quality SOPs, work instructions, templates, and tools. You will also help evaluate innovative ideas and turn them into practical improvements that strengthen clinical operations. Success requires strong judgment, communication, organization, and the ability to influence stakeholders within a matrix structure. This is an opportunity to contribute to reliable clinical development practices while supporting a mission focused on improving access to innovative medicines.

Responsibilities

• Lead and support global clinical process management activities across Global Clinical Operations.
• Promote efficient, consistent, sustainable, and compliant processes and standards across clinical operations.
• Serve as the primary Global Clinical Operations Excellence point of contact for assigned processes, including SOPs, work instructions, and related standards.
• Collaborate with Global Process Owners and subject matter experts to develop and maintain procedural documentation.
• Lead or contribute to the technical writing of SOPs, work instructions, templates, tools, and other controlled documents.
• Lead clinical process management initiatives in collaboration with relevant governance and process management groups.
• Assess the need to create, revise, harmonize, or optimize controlled documents and operational processes.
• Support continuous improvement, change management, and implementation activities associated with process changes.
• Identify innovative ideas that can improve clinical operations processes and help move them from concept through implementation.
• Facilitate stakeholder evaluation, alignment, decision-making, and follow-through for process improvement initiatives.
• Lead document review and approval workflows, ensuring appropriate stakeholder engagement and completion.
• Review processes owned by other functions when they have an impact on clinical operations processes or related standards.
• Establish and maintain effective partnerships with Global Clinical Operations and cross-functional stakeholders.
• Collaborate with GCP Compliance, Learning and Development, and other relevant functions to ensure process alignment.
• Contribute to the strategic development and improvement of training materials related to clinical operations processes.
• Promote alignment with ICH-GCP principles and applicable clinical trial regulatory requirements.
• Provide matrix leadership and influence across global teams and functional boundaries.
• Support consistent adoption and sustainment of new or improved processes across the organization.
• Contribute to a culture of quality management, operational excellence, continuous learning, and process improvement.

Requirements

• Bachelor’s degree in a relevant discipline is required, preferably in science, healthcare, or a related field.
• Master’s degree or other relevant postgraduate qualification is preferred.
• Minimum of 8 years of professional experience within the pharmaceutical and/or biotechnology industry.
• Extensive knowledge of clinical operations processes, ICH-GCP, and compliance management.
• Strong understanding of applicable clinical trial regulations and their practical application within clinical operations.
• Demonstrated experience in clinical trial process design, harmonization, optimization, and implementation.
• Experience working effectively in a global, matrixed organization.
• Proven ability to collaborate with stakeholders across functions, geographies, and levels of seniority.
• Experience developing, reviewing, and implementing SOPs, work instructions, templates, and other procedural documentation.
• Strong process improvement and quality management orientation