Lifecycle Safety Project Startup Lead

PURPOSE

This role will be responsible to lead the delivery and execution of project start-up 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 Start-up 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 on-going continuous improvement in an effort to ensure the maturity of the project start-up 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.

RESPONSIBILITIES

• As Project Start-up Lead, drive the execution of all core project start-up 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 defences. 
• Provide monthly reports to customers and key internal stakeholders on the status of project start-up activities. 
• Mentor incoming project leads, as needed, to their roles and deliverables, e.g. Project Manager, Quality Manager, Training Manager

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• 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.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• 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.).

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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

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 IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.