Clinical Process Change Manager

Location: Remote from Germany, Italy, Portugal, Spain, Austria, or the United Kingdom; listed locations include Frankfurt, Milan, Lisbon, Barcelona, Madrid, Vienna, Mannheim, and Belfast.

Company

hirify.global Strategic Solutions provides sponsor-dedicated clinical development services through a global functional service provider model.

What you will do

• Manage the development, revision, and retirement of controlled documents, including SOPs, work instructions, templates, forms, job aids, and guidance documents.
• Drive cross-functional process initiatives and operational projects from initiation through implementation.
• Establish timelines, responsibilities, decision points, and approval workflows while managing multiple document revisions.
• Identify risks, inconsistencies, gaps, ambiguities, and procedural issues affecting clinical trial execution.
• Facilitate stakeholder meetings, resolve differing perspectives, and drive consensus across senior leaders, subject-matter experts, quality representatives, and operational teams.
• Ensure clear procedural language, version control, formatting, references, and alignment with corporate standards.

Requirements

• Bachelor’s degree in a relevant scientific or healthcare-related field.
• 7–10+ years of sponsor or CRO clinical research experience, ideally in late-phase clinical operations, clinical project management, quality assurance, process excellence, or a related function.
• Deep knowledge of Good Clinical Practice (GCP) and the operational realities of global clinical trial execution.
• Experience leading complex cross-functional initiatives without direct authority.
• Familiarity with procedural governance, controlled document management, CAPAs, quality systems, and change management principles.
• Experience authoring, revising, reviewing, or governing procedural documentation.

Culture & Benefits

• Remote working arrangement within the listed European locations.
• Annual leave entitlements and country-specific health insurance options.
• Retirement planning offerings and life assurance.
• Global employee assistance support available around the clock.
• Optional benefits may include childcare vouchers, bike purchase schemes, discounted gym memberships, travel passes, and health assessments.
• Inclusive workplace focused on equal opportunity, accessibility, and employee well-being.