Real-World Research (RWR) Principal Business Operations Lead, multiple UK/EU locations

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

This role can be flexibly based in the UK or other European locations

Picture Yourself At Parexel:

The Real-World Research (RWR) Principal Business Operations Lead (PBOL) is a senior role within the RWR Project Management Office (PMO), positioned as a key step towards achieving a director-level position. 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

Required skills, experience, and education:

• Bachelors’ degree in life science as a minimum

• At least 3 years of global project management experience in clinical research

• Demonstrable clinical experience in RWR-oriented clinical research, both interventional and observational, with a strong understanding of data applications across the clinical research spectrum. This experience includes overseeing the clinical operations strategy and execution of trials, ensuring they are conducted ethically, safely, and effectively; monitoring study sites, maintaining compliance with protocols, safeguarding patient safety through site visits, data review, and liaising with investigators.

• 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