Clinical Process Change Manager

This is a fully remote position, open to applicants in United Kingdom, +5 more countries.

📋 Description

• Oversee and coordinate all facets of controlled document creation, modification, and retirement

• Ensure that procedures and business processes are compliant, consistent, scalable, and efficient

• Offer process expertise and collaborate cross-functionally with pertinent stakeholders

• Lead cross-functional special projects and initiatives related to business processes and GCO department operations

• Proactively drive projects from the initiation phase through to implementation

• Set clear timelines, roles, responsibilities, and decision-making points

• Anticipate risks and challenges before they affect delivery

• Manage multiple document revisions at various stages of development

• Secure timely feedback, reviews, endorsements, and approvals from various stakeholders

• Convert complex operational concepts into clear, concise procedural language

• Facilitate meetings and keep discussions focused on decisions and outcomes

• Navigate disagreements and foster consensus among stakeholders

• Communicate effectively with senior leaders, functional subject matter experts, quality representatives, and operational teams

• Identify inconsistencies, gaps, ambiguities, and procedural risks

• Ensure alignment of documents with corporate standards

• Maintain strict adherence to version control, document formatting, references, workflows, and approval requirements

⛳️ Requirements

• Bachelor's degree in a relevant scientific discipline or a healthcare-related field

• 7-10+ years of experience in clinical research as a Sponsor or CRO, preferably in late phase Clinical Operations, Clinical Project Management, Quality Assurance, Process Excellence, or a similar role

• Comprehensive understanding of Good Clinical Practice (GCP) and the operational realities of executing global clinical trials

• Proven experience in managing complex cross-functional initiatives that necessitate coordination, influence, and accountability without direct authority

• Strong knowledge of procedural governance, controlled document management, CAPAs, quality systems, and change management principles

• Experience in authoring, revising, reviewing, or governing procedural documents such as SOPs, Work Instructions, Templates, Forms, Job Aids, and Guidance Documents

• Experience leading high-complexity cross-functional projects with team members both within and outside the department

• Legal eligibility to work in the country where the position is located

🏝️ Benefits

• Competitive base salary and performance-related incentives

• Health and wellbeing programs including medical, dental, and vision coverage where applicable

• Retirement and pension plans

• Life assurance and disability coverage

• Employee assistance programs and wellbeing resources

• Learning and development opportunities through structured training and career pathways