[Hiring] Senior Manager, Integrated Clinical Trial Data Process Excellence and Delivery @LanceSoft

Role Description

• Provide process-development expertise and operational delivery support for assigned Clinical Trial Delivery and Pharmacovigilance initiatives.
• Develop process maps, RACIs, procedures, work instructions, job aids, and related implementation materials based on approved requirements and stakeholder input.
• Facilitate workshops, stakeholder interviews, documentation activities, and project tracking to support effective and compliant ways of working.
• Partner with accountable Client stakeholders, who retain process ownership, prioritization, governance, decision-making, and final approval responsibilities.

Qualifications

• Bachelor’s degree or international equivalent required; degree in life sciences or a related discipline preferred.
• Six or more years of relevant experience in the pharmaceutical industry, biotechnology industry, or a clinical research organization.
• Strong written and verbal communication, organization, facilitation, interpersonal, conflict-resolution, and problem-solving skills.
• Demonstrated ability to collaborate effectively in a global, cross-functional, and matrixed environment.
• Ability to organize and manage multiple assigned deliverables, meet agreed timelines, and provide clear and timely status updates.
• Ability to adapt to changing priorities, incorporate stakeholder feedback, and work independently within established scope and direction.
• Global or international experience preferred, including the ability to collaborate with stakeholders across locations and time zones.

Requirements

• Operational experience in Clinical Operations, Study Management, Data Management, and/or Pharmacovigilance; Global Regulatory Affairs experience is beneficial but not required.
• Demonstrated experience translating complex operational requirements and existing documentation into clear process maps, RACIs, procedures, work instructions, job aids, and related process content.
• Working knowledge of GxP quality systems, controlled-document practices, clinical trial and/or PV processes, and applicable regulatory expectations, including ICH GCP.
• Experience facilitating cross-functional workshops and subject matter expert discussions to gather requirements, clarify roles and handoffs, and confirm proposed process content.
• Ability to independently develop assigned deliverables within agreed requirements and scope.
• Experience with process-mapping tools such as Lucid and document-review workflows such as Please Review is preferred.

Company Description

This role provides consulting expertise and execution support for assigned process-development initiatives and does not serve as the dedicated Process Lead for a functional portfolio.