Clinical Trial Delivery Consultant - Remote

Job Title: Clinical Trial Delivery Consultant
Location: Remote
Duration: 6+ months with extension or full time

Job Summary

• We are seeking a Consultant, CTD and PV Process Excellence to provide process-development expertise and operational delivery support for Clinical Trial Delivery (CTD) and Pharmacovigilance (PV) initiatives.
• The consultant will work with global, cross-functional stakeholders to understand business requirements, develop and improve processes, create controlled documentation, facilitate workshops, and track assigned initiatives through completion.
• This role supports process development and execution; accountable business stakeholders retain ownership, prioritization, governance, decision-making, and final approval responsibilities.

Key Responsibilities

• Partner with stakeholders to execute assigned process development and process improvement initiatives within Clinical Trial Delivery and Pharmacovigilance.
• Develop process documentation including process maps, RACI matrices, procedures, work instructions, job aids, and implementation materials.
• Create and maintain Lucid process maps based on approved requirements, existing documentation, and stakeholder input.
• Facilitate cross-functional workshops and SME interviews to gather requirements, clarify roles and handoffs, and validate proposed processes.
• Draft and revise process documentation in accordance with applicable quality and document-control requirements.
• Coordinate document-review workflows, including preparing review packages, tracking comments, facilitating comment reconciliation, and maintaining review records.
• Maintain project plans, status reports, action/decision logs, RAID logs, and deliverable trackers.
• Identify and document risks, dependencies, unresolved questions, and required decisions.
• Provide process-development expertise and recommendations within the assigned scope and escalate complex decisions, governance matters, and approval requirements to the appropriate stakeholders.

Required Qualifications

• Bachelor's degree or international equivalent required; Life Sciences or related discipline preferred.
• 6+ years of relevant experience in the pharmaceutical, biotechnology, or CRO industry.
• Operational experience in one or more of the following:
• Clinical Operations
• Clinical Trial Delivery
• Study Management
• Data Management
• Pharmacovigilance
• Experience translating complex operational requirements into:
• Process maps
• RACIs
• Procedures

Work instructions

• Job aids
• Process documentation
• Working knowledge of GxP quality systems, controlled-document practices, clinical trial and/or PV processes, and ICH GCP.
• Experience facilitating cross-functional workshops and SME discussions.
• Strong written and verbal communication, organization, facilitation, interpersonal, conflict-resolution, and problem-solving skills.
• Ability to independently manage multiple deliverables and meet agreed timelines.
• Ability to collaborate effectively within a global, cross-functional, matrixed environment.