(Associate) 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:

• Provide strategic support for 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

Education Required:

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

Other Qualifications:

• Relevant Bachelor’s degree minimum – preferred science/healthcare discipline
• Typically 12 or more years of progressive experience in the pharmaceutical, biotechnology, or clinical research sector.
• Demonstrated experience leading complex global or regional clinical operations programs, process portfolios, or enterprise-wide improvement initiatives in a matrix organization.
• Expert knowledge of clinical operations processes, ICH-GCP, clinical trial regulations, inspection readiness, and compliance expectations, with the ability to translate requirements into practical global standards.
• Proven experience in end-to-end process design, governance, harmonization, optimization, implementation, adoption, and lifecycle management.
• Demonstrated ability to operate as a Global Process Owner, senior process lead, or trusted advisor to senior stakeholders, with strong judgement and accountability for outcomes.
• Strong change management capability, including stakeholder engagement, communication, training strategy, implementation planning, and sustainment.
• Excellent influencing, facilitation, negotiation, problem-solving skill.
• Strong analytical and risk-based decision-making skills, with experience using data and performance measures to evaluate process effectiveness and drive improvement.
• Excellent written and verbal communication skills, with the ability to present complex topics clearly to both technical and executive audiences.
• Demonstrated commitment to quality, operational excellence, collaboration, and continuous improvement.

Travel:

• According to the requirements.

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