Safety Project Manager

About this role

Job Overview Accountable for management and service delivery excellence of a range of large sized regional and global projects as assigned, covering single or multiple Lifecycle Safety functions (clinical trial and / or post-market). Provide leadership and accountability for customer-facing activities and oversight of operational service delivery, working cross-functionally and across the opportunity lifecycle, integrating delivery into one seamless and transparent program for customers, aligned by accounts. May Collaborate with global management team and integrated partners to develop and implement strategic initiatives/solutions to expand business, partnership, strengthen overall relationship and ensure global consistency

Essential Functions • Manage customer interface and communication for assigned projects/programs. Represent Lifecycle Safety on projects/programs; serve as primary point of contact within Lifecycle Safety for all internal and external customers; liaise between internal/external customers and Lifecycle Safety Operational teams. • Manage customer deliverables for assigned projects/programs. Tactical, day-to-day customer-facing leadership at project/program level. Responsibilities include project planning (timelines, deliverables), scope management, quality management and project financial management. • May act as an account owner over a program or customer portfolio and therefore report program/portfolio level metrics and provide oversight of projects they do not directly lead. • Performs role of solution architect responsible for crafting and defending proposed solutions to new standalone Safety business opportunities. Formulates operational budgetary assumptions and takes decisions to steer the creation of the budget, fulfil required customization of text and data. Acts autonomously as the Safety Subject Matter Expert (SME) and single point of contact for Governance, Executives and Integrated Partners in construction of proposed solution and defends the strategy and pricing from initiation through to delivery. • Represents as Safety SME. Provide leadership and accountability for customer-facing collateral and operational support to deliver key customer messages, working cross-functionally and across the opportunity lifecycle, integrating lifecycle safety core message delivery into customer facing material, presentations and meetings. Collaborate with senior leadership to implement strategic initiatives and ensure global consistency. • Provide leadership structure for customer service interface from scoping stage, through proposal generation, bid defense to transition of work and service delivery; and throughout the development and commercial life cycle of the product. • Manage finances for assigned projects/programs. Update financial systems, revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders, etc. • Ensure financial project performance through oversight of key performance metrics (i.e. revenue, direct costs, time-sheet costs, contribution margin). • Develop specialist expertise and may act as a Subject Matter Expert (SME) on departmental, regional or global initiatives. • Work with sales and proposals to ensure rapid, seamless, tailored responses to opportunities. Drive business growth by improving customer loyalty through enhanced customer relations, service delivery excellence and excellent customer communication. • Manage start-up of new projects using standard operating procedures and best practices, including identifying potential risks during project initiation and implementing mitigation measures to ensure seamless delivery at maintenance stage. • Lead meetings with internal and external stakeholders. Provide project status updates, defines processes, project/planning strategy. • Provide leadership for Lifecycle Safety virtual project teams: keep local/global Lifecycle Safety team current on project developments; lead internal Lifecycle Safety team meetings to review project processes and status. Work closely with Lifecycle Safety Operational teams, to ensure projects/programs are delivered in accordance with customer expectations. • Facilitate sales activities, and sales presentations (capabilities, bid defenses) and proposal development (strategy, costs and text), as needed. • Incorporate strategic options when defining project/program scope and processes with customer. • Develop customer relationships into partnerships; manage accounts targeting extended business relationship throughout lifecycle. Focus on customer loyalty and contract renewal. Facilitate discussions on new business opportunities with existing customers. • Work in a customer centric fashion analyzing current and future customer needs and actively developing innovative, cross- functional strategic solutions within Lifecycle Safety service lines to meet customer needs. • Actively contribute during client and internal audits and inspections for assigned project. Liaise with Quality Assurance staff and management in the compilation of corrective action plans. • Collaborate with Lifecycle Safety Management to resolve problem areas and customer needs ensuring global consistency.

Qualifications • Bachelor's Degree Health science or other directly related field or equivalent experience • 4 to 6 years' clinical research experience in a Contract Research Organization or Pharmaceutical company combining 4 years of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc.) and 2 years' project management experience • Strong knowledge of applicable global, regional and local clinical research regulatory requirement; i.e.   Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, IQVIA Standard Operating Procedures. • Working knowledge of Lifecycle Safety service lines; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills. •

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