USA - Senior Manager, Integrated Clinical Trial Data Process Excellence and Delivery

Senior Manager, Integrated Clinical Trial Data Process Excellence and Delivery
Location: Remote
Pay Rate: $86.67–$89.66/hr.
Duration: 6 months

Job Description

• Provide process-development expertise and operational delivery support for assigned Clinical Trial Delivery (CTD) and Pharmacovigilance (PV) initiatives.
• Develop process content packages, including process maps, RACIs, procedures, work instructions, job aids, and implementation materials.
• Create and update Lucid process maps using approved requirements, existing documentation, and stakeholder input.
• Facilitate cross-functional workshops and subject matter expert interviews to gather requirements, document process steps, and clarify roles and handoffs.
• Draft and revise process documentation in accordance with applicable quality and document-control requirements.
• Coordinate PleaseReview workflows, including review packages, comment tracking, reconciliation discussions, and review records.
• Maintain project plans, status reports, action and decision logs, RAID logs, and deliverable trackers.
• Identify and document risks, dependencies, unresolved questions, and required decisions.
• Provide process-development expertise within assigned scope and escalate governance, prioritization, and approval matters to accountable stakeholders.

Education

• Bachelor’s degree or international equivalent required.
• Degree in Life Sciences or a related discipline preferred.

Required Skills

• 6+ years of relevant experience in the pharmaceutical, biotechnology, or clinical research organization (CRO) industry.
• Operational experience in Clinical Operations, Study Management, Data Management, and/or Pharmacovigilance.
• Experience translating complex operational requirements and existing documentation into process maps, RACIs, procedures, work instructions, job aids, and related process content.
• Working knowledge of GxP quality systems, controlled-document practices, clinical trial processes, and/or Pharmacovigilance processes.
• Knowledge of applicable regulatory expectations, including ICH GCP.
• Experience facilitating cross-functional workshops and SME discussions to gather requirements and confirm process content.
• Ability to independently develop assigned process deliverables within defined requirements and scope.

Preferred Skills

• Experience with Lucid for process mapping.
• Experience with PleaseReview document-review workflows.
• Global Regulatory Affairs experience.
• Global/international experience working across locations and time zones.