Job Description

Associate Safety Project Director



Primary Location: Durham, North Carolina, United States Full time R1190446 Date Posted: 03/08/2021

Job description

Job Overview
Provide strategic leadership at customer (or strategic) account level for large post-marketing, clinical trial or combination programs or customer accounts, as assigned by senior management team. Act as a senior level point of contact throughout project duration for local and globally scoped deliverables with single/multiple Lifecycle Safety functions. Collaborate with global management team and integrated partners to develop and implement strategic initiatives / solutions and ensure global consistency.

Essential Functions
Manage customer interface and communication for large programs or standalone projects. 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.
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.
Attend Joint Operating Committee Meetings and / or Governance meetings to provide portfolio level quality and compliance metrics, to provide other portfolio level updates, and to partner with customers at a Senior Management Level.
Lead internal escalation meetings to ensure quick response to any quality concerns or customer escalations, ensuring appropriate representatives from stakeholders and operational management are involved as appropriate.
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 specialized expertise across the Pharmacovigilance spectrum (e.g. Global Regulatory, Regulatory reporting requirements), and apply this expertise within assigned projects, and cascade knowledge to PV Solutions team as appropriate
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
Identify and drive departmental initiatives aimed at enhancing customer service, efficiency, quality, or employee engagement
Represent LS Leadership at select external and internal meetings.
Takes on a higher level of leadership within the department to mentor and support junior leads.
Collaborate with Lifecycle Safety Management to resolve problem areas and customer needs ensuring global consistency
Perform other duties as assigned

Qualifications
Bachelor's Degree Health science or other directly related field Req
Other Project Management Professional (PMP) Certification Pref
6 to 7 years' clinical research experience in a Contract Research Organization or Pharmaceutical company combining 6 years of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc.) and 3 years' project management experience Req Or
Equivalent combination of education, training or experience Req
In-depth 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.
In-depth knowledge of Lifecycle Safety service lines; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills.
Strong team management and leadership skills, conflict management.
Strong project management; planning and organizational skills.
Effective verbal and written communication skills including ability to network and lead teleconferences.
Effective collaborative, organizational and delegation skills.
Ability to establish and maintain effective working relationships with coworkers, managers and customers.
Ability to deliver on multiple projects and manage competing priorities.
Ability to manage ambiguity.
Effective business focus, marketing, sales skills.
Proven strong presentation; report writing skills and customer focus skills.
Ability to achieve results through communication, facilitation, negotiations in a matrix service delivery environment with shared accountabilities.
Independent judgment, negotiating, decision-making, and problem-solving skills.
Effective business acumen and financial analytical skills, tactical planning, budgeting.
Customer focused with effective relationship building skills.
Effective motivating, influencing and conflict resolution skills.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIAs Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.