Senior Safety Project Lead

Job Overview
Responsible for management and service delivery excellence for assigned projects, 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. 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. Represent Lifecycle Safety on projects and 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 and bring continuity to project design and delivery through customer delivery. Tactical, day-to-day customer-facing leadership at project level. Responsibilities include project planning (timelines, deliverables), defining project/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 and structure for customer service interface from scoping stage, through proposal generation, bid defence to transition of work and service delivery; throughout the development and commercial lifecycle of the product

• Manage finances for assigned projects. Responsible for updating financial systems. Work closely with manager on revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders, etc.

• Develop specialist expertise and may act as a Subject Matter Expert (SME) on departmental or global initiatives

• Support 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.

• Attend meetings with internal (IQVIA cross functional project team members) and external (Customers and/or oversight group members) stakeholders. Provides project status updates, defines processes, project planning/strategy.

• 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.

• Participate in sales activities, and sales presentations (capabilities, bid defenses) and proposal development (strategy, costs and text), as required.

• Contributes during client and internal audits and inspections for assigned projects. Liaise with Quality Assurance staff and management in the compilation of Corrective Action Plans.

• Work closely with Lifecycle Safety management to address problem areas and customer needs.

• Perform other duties as assigned.

Qualifications

• Bachelor's Degree Health science or other directly related field

• 2-3 years' experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety Publishing, Risk Management etc) with project management experience

• Equivalent combination of education, training or experience

• 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.

• Willingness to increase knowledge across Lifecycle Safety service lines and develop new skills.

• Strong prioritization (critical timelines), planning and organizational skills.

• Effective verbal and written communication skills including ability to work and lead teleconferences.

• Effective collaborative, organizational and delegation skills.

• Independently work on multiple projects and manage competing priorities.

• Ability to manage ambiguity.

• Strong presentation (independently present at internal/external meetings) skills; report writing skills and customer focus skills.

• Accountability, ownership and transparency.

• Demonstrates independent judgment, negotiating, decision-making, and problem-solving skills.

• Possesses knowledge of business acumen and financial analytical skills, tactical planning, and budgeting.

• Creative and innovative, initiative and pro-active.

• Effective motivating, influencing and conflict resolution skills.

• Ability to establish and maintain effective working relationships with coworkers, managers and customers.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more