Senior Manager, Integrated Clinical Trial Data Process Excellence and Delivery

Job Description:

Objectives/Purpose (3-4 Bullets)

• 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.

Accountabilities (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5-10 bulleted task statements should be identified).

The Consultant, CTD and PV Process Excellence responsibilities include:

• Partner with accountable Client stakeholders to execute assigned process-development and improvement activities for CTD and PV initiatives.
• Develop process content packages, including process maps, RACIs, procedures, work instructions, job aids, implementation materials, and other supporting documentation, as applicable.
• 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, clarify roles and handoffs, and confirm proposed content.
• Draft and revise process documentation with document owners and subject matter experts in accordance with applicable quality and document-control requirements.
• Coordinate activities for assigned Please Review workflows, including preparation of review packages, tracking comments, scheduling comment-reconciliation discussions, and maintaining review records.
• Maintain project plans, status reports, action and decision logs, RAID logs, and deliverable trackers for assigned initiatives.
• Identify and document risks, dependencies, unresolved questions, and required decisions for assigned initiatives.
• Provide process-development expertise and recommendations within the assigned scope, escalating prioritization needs, complex decisions, governance matters, and items requiring final approval to accountable Client stakeholders.

Core Elements Related to This Role (Describe what is critical and/or what differentiates this role).

• 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.

Education, Behavioural Competencies and Skills: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)

• 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.

Additional Information (Add Any Information Legally Required For Your Country Here)

• 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.