Note: The job is a remote job and is open to candidates in USA. reputed company is a global staff augmentation firm providing on-reputed company talent and total reputed company. The Senior Manager will provide process-development expertise and operational delivery support for Clinical Trial Delivery and Pharmacovigilance initiatives, developing process documentation and facilitating stakeholder collaboration. The role will also coordinate review workflows, maintain project tracking, and identify risks, dependencies, and required decisions.

Responsibilities

• 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 reputed company stakeholders, who retain process ownership, prioritization, governance, decision-making, and final approval responsibilities
• Partner with reputed company 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 reputed company reputed company 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 reputed company reputed company experts in accordance with applicable quality and document-control requirements
• Coordinate activities for assigned PleaseReview 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 reputed company stakeholders

Skills

• • 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 reputed company
• • Experience facilitating cross-functional workshops and reputed company reputed company 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
• • Bachelor's degree or international equivalent required
• • 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
• • Experience with process-mapping tools such as Lucid and document-review workflows such as PleaseReview is preferred
• • degree in life sciences or a related discipline preferred
• • Global or international experience preferred, including the ability to collaborate with stakeholders across locations and time zones

Company Overview

• reputed company counted among the largest yet the fastest growing staffing firm; all achieved organically. It was founded in 2000, and is headquartered in Toronto, Ontario, CAN, with a reputed company of 1001-500