Associate Director / Director Global Clinical Process Management Lead

General Description:

The Global Clinical Process Management Lead is responsible for leading and supporting global clinical process management activities within Global Clinical Operations. Working collaboratively with GCO stakeholders globally, this role promotes efficient, consistent, sustainable, and compliant processes and standards across GCO, while supporting innovative ideas that strengthen processes and ensuring effective alignment and follow-through from concept through implementation. The role also ensures alignment with ICH-GCP and applicable regulatory requirements.

Responsibilities:

• Execute global clinical process management activities within GCO to promote efficiency, consistency, sustainability, and compliance with applicable regulatory requirements across GCO processes and standards.

• Serve as the primary GCOE point of contact for one or more GCO processes, including SOPs, Work Instructions, and related standards.

• Contribute to content development and collaborate with GCO Global Process Owners and Subject Matter Experts, or act as the Global Process Owner as appropriate, in the technical writing of GCO procedural documents, including SOPs, Work Instructions, templates, and tools.

• Lead GCO process management initiatives in collaboration with GCPC, including assessing the need to revise or create controlled documents and supporting continuous improvement, change management, and implementation activities.

• Identify, support, and help advance innovative ideas that improve GCO processes, enabling effective evaluation, stakeholder alignment, and follow-through from concept through implementation.

• Lead document review and approval workflows.

• Advise on and review processes owned by other functions that impact GCO processes and related standards.

• Establish and maintain effective partnerships with relevant GCO and cross-functional groups, including GCP Compliance, Learning and Development, and other stakeholders as needed.

• Contribute to the development and strategic direction of training materials related to GCO processes.

Supervisory Responsibilities:

• Matrix supervisory

Computer Skills:

• Efficient in Microsoft suite (Excel, Outlook, Word, PowerPoint, Project)

Other Qualifications:

• Fluent English (Oral; Written)

• Relevant Bachelor’s degree minimum – preferred science/healthcare discipline

• Minimum of 8 years of experience in pharmaceutical and/or biotechnology sector

• Extensive knowledge of clinical operations process, ICH-GCP and compliance management; including application of clinical trial regulation/s

• Experience in clinical trial process design, harmonization/optimization and implementation.

• Experience working in matrix environment and in global teams

• Excellent interpersonal, problem-solving, negotiation and conflict resolution skills

• Excellent organizational skills and a pre-disposition to quality management and process improvement

• Effective communicator (oral and written)

• Strong presentation skills

Education Required:

• Bachelor’s degree required, master’s degree or other relevant post graduate qualification preferred.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.