Real-World Research (RWR) PMO Principal Business Operations Lead

The Real-World Research (RWR) Principal Business Operations Lead (PBOL) is an advanced role within the RWR Project Management Office (PMO). The PBOL act as a team leader responsible for coordination of RWR internal projects and initiatives with the goal to bring consistency, predictability, and quality control to operations and to RWR services across Parexel. What You'll Do At Parexel: RWR business operations

• Plan, execute and deliver RWR internal projects and initiatives, ensuring they meet the needs and goals of the organization
• Develop and implement PMO processes, policies and tools driving continuous improvement in project management practices
• Define and implement project management methodologies to manage projects effectively
• Drive the development and rollout of PMO tools that will plan, manage, and track projects and/or activities
• Support operational functions in the development/ revision of RWE specific content in controlled documents/ Managed information as required
• Define, develop, and establish metrics and process health measurement parameters for RWR operating models and processes
• Build a delivery framework and expert team to develop best-in class solutions, technology and/or Real-World Data enabled as required, for all types of RWR studies
Project Management
• Lead the development of project /initiative planning documents e.g., Roles and Responsibilities, Project Plan, Communication Plan, Risk Analysis and training materials
• Monitor and oversee all aspects of RWR internal projects/ initiatives delivery, ensuring adherence to scope, timelines, and budget
• Develop, review, and finalize initiative delivery and ROI metrics influenced by RWR delivery with supportive RWR finance teams and leadership
• Ensure the RWR initiative components are completed within budget specifications and schedule
Risk Management
• Identify, assess, and manage project/initiative risks and issues.
• Implement mitigation strategies to address potential project challenges
Team Leadership
• Lead a cross functional project/initiative team, fostering a culture of excellence and continuous improvement
• Works with RWR PMO leadership to identify / address gaps and challenges in team member delivery to ensure optimal performance
Communication
• Engage with key stakeholders, business partners and operational functions to ensure project alignment and successful delivery
• Lead team meetings on a regular basis with initiative team to ensure initiative objectives are met; ensure the on-going communication to team members of the scope of work, timeline and initiative goals, technical information, and input from across functions throughout the initiative.
• Develop and maintain working relationships with groups not limited to Business Partners, Initiative team, RWR operational units, Quality Management, Solutions Consulting, Data privacy, Legal & Risk Management, Leaders of internal businesses, and vendors both data & technology
Quality Management and Compliance
• Ensure compliance with policies, regulations, SOPs, and privacy / data security standards
• Support quality control of inspection-ready files (e.g., TMF, qualified record repository)
• Identify quality issues, ensuring they are raised in relevant system and closed according to requirements
• Support audit preparation and represent RWR in audits and inspections for internal, sponsor, and regulatory agencies as needed
  
  Bachelors' degree in life science as a minimum
• At least 3 years of global project management experience in clinical research
• Demonstrable experience in RWR-oriented clinical research, both interventional and observational, with a good understanding of data applications across the clinical research spectrum
• Working knowledge in developing and implementing standard operating procedures (SOPs) and business processes and tools
• Familiarity with developing and implementing operational models in clinical research
• Proven experience in managing operational projects and initiatives, including planning, budgeting, and resource allocation preferably in a research or healthcare setting
• Knowledge of global data security, patient privacy/consent provisions, data and privacy regulations impacting RWR clinical research
• Ability to form strong partnerships with cross-functional stakeholders, including Real World Data, commercial, and operational teams and ability to build confidence and trust in solutions and services
• Knowledge of Real-World Data access/acquisition requirements, study delivery processes, technology selections, and project team configurations
• Knowledge of relevant data sources (e.g., EMR, claims, registries), data applications (e.g., mHealth, sensors/wearables), data flows, data repositories
• Advanced knowledge in Project Management and Process Development Software and tools
• Excellent organizational skills, must be able to manage multiple projects with high priority
• Ability to work independently
• Ability to lead a decentralized team and ability to work/lead others through aggressive challenges, obstacles, deadlines, and changes
• Excellent interpersonal skills, presentation, and written communication skills
  
  When you join us, you're joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there's no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change - forever. And together, we'll do it With Heart ., Parexel is among the world's largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.