Lifecycle Safety- Project Start-Up Lead (R1091069) in Dublin, Ireland at IQVIA™

发布日期: 8/19/2019


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IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.


This role will be responsible to lead the delivery and execution of project startup tasks and core constructs for one or more post-marketing, clinical trial or combination programs, as assigned by LCS senior management. With customer-facing responsibility, the Project Startup Lead will provide strategic leadership and matrix project management for globally scoped deliverables; collaborate with a global team in a joint effort to meet customer expectations; recommend and implement ongoing continuous improvement in an effort to ensure the maturity of the project startup and transition team; seek to ensure compliance with agreed-upon SLA’s and KPI’s; and ensure that our deliverables provide the highest level of quality and value to our customers.


  • As Project Start-up Lead, drive the execution of all core project startup tasks, including, but not limited to: the integrated project plan, resource plan, safety plans, communication, quality and training plans, facilities plan; activities include database setup and migrations.
  • Provide direct customer support and internal coordination with Lifecycle Safety functional teams and business partners including, but not limited to, Safety Systems, IT, contracts, proposals, HR and finance; may represent LCS Leadership at select external and internal meetings.
  • With management oversight, may help negotiate Budget, Work Orders, Service Level Agreements and other contractual documentation directly with the relevant customer contact.
  • Work with customers through the project initiation phase to develop, implement and track key performance indicators (KPIs) and develop timelines and processes for tracking KPIs on an account/portfolio level.
  • Ensure consistent standardized processes are implemented globally and program deliverables meet expected quality, financial and productivity targets.
  • Ensure quick response to any quality concerns or customer escalations, ensuring appropriate representatives from stakeholders and operational management are involved as appropriate.
  • May provide input into the strategy for LCS project proposals and RFPs and represent Lifecycle Safety at clinical add-on and/or standalone bid defenses. 
  • Provide monthly reports to customers and key internal stakeholders on the status of project startup activities. 
  • Mentor incoming project leads, as needed, to their roles and deliverables, e.g. Project Mgr, Quality Mgr, Training Manager


  • In depth knowledge and understanding of Lifecycle Safety service lines; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills.
  • In depth knowledge of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
  • Strong staff management; coaching and leadership skills.
  • Strong project management; strategic planning; delegation and organisational skills.
  • Proven ability to work on multiple projects and manage competing priorities.
  • Autonomous independent decision-making; problem solving and judgment skills.
  • Excellent verbal/written communication and report writing skills.
  • Strong business acumen; financial management and budgeting skills.
  • Strong customer focus; account and alliance management and experience in customer contracting models.
  • Proven ability to professionally network; present and lead at meetings/ teleconferences.
  • Ability to achieve results through communication, facilitation, negotiations in a matrix service delivery environment with shared responsibilities.
  • Demonstrate excellent flexibility; self-motivation; creativity; innovation and solutions driven approach.
  • Ability to establish and maintain effective working relationships with co-workers, managers and customers and clients.


  • Bachelor's degree or educational equivalent in health science or other directly related field and 8 years' clinical research experience in a Contract Research Organization or Pharmaceutical company combining 5 years of Lifecycle Safety experience (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management, etc.).

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Job ID: R1091069