PMO Principal Business Operations Lead

November 28

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Description

• 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... • 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... • 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. • Identify, assess, and manage project/initiative risks and issues. Implement mitigation strategies to address potential project challenges... • Lead a cross functional project/initiative team, fostering a culture of excellence and continuous improvement. • Engage with key stakeholders, business partners and operational functions to ensure project alignment and successful delivery...

Requirements

• 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... • 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