Principal Business Process Leader, Scientific Data Organization - selected EU/UK locations

This role can be flexibly based in the UK and select EU locations

Picture Yourself At Parexel:

The primary role of the Principal Business Process Lead (principal BPL) is to understand Parexel’s business partner (aligned internal departments) and Scientific Data Organization (SDO) objectives and requirements in order to lead a multidisciplinary project team in the development and implementation of rapid, reliable and repeatable solutions and services to SDO internal customers.

The Principal Business Process Lead will work across all aspects of Real-World Evidence (RWE) study designs, data sources and technologies, as well as engage with various stakeholders including RWE operations, Epidemiology, Medical and Biostatistics.

The Principal Business Process Lead will competently and independently lead small and mid-size projects and/or initiatives with little guidance.

What You'll Do At Parexel:

Leading internal projects and initiatives

• Lead, facilitate and deliver internal projects and initiatives on the real-world data and evidence space that leverage best in class design, expertise & technology, across Parexel Business Partners.

• Lead, facilitate and deliver infrastructure development across RWE functions, such as tracking tools, processes and toolkits, capacity management, metrics development etc.

• Work independently to build the understanding, delivery framework, expert team to develop RWD and technology enabled solutions for all types of RWE projects.

Project Management

• Work closely with SDO / RWE team and Business Partners to define and refine the requirements / goals of internal projects and initiatives to support detailed planning and delivery.

• Manage the set-up of the RWE/ SDO centered or supported components of initiative delivery.

• Lead development of and input to initiative plan elements into initiative planning documents where appropriate (e.g. Roles and Responsibilities, Project Plan, Communication Plan, Risk Analysis).

• Facilitate the definition, input and approval of SDO budget in relation to SDO resource, data source procurement and / or SDO covered technology components for any given initiative.

• Lead and document the discussions during all phases of an initiative, ensuring the RWE/SDO scope of the initiative is well understood by the SDO / business partner, initiative team and all supporting functions.

• Ensure that initiative management tools are in place to support collective initiative management across functions as well as to easily support SDO and BO oversight.

• Ensure the SDO - initiative components are completed within schedule and according to budget specifications.                                                                          

• Ensure that SDO-initiative elements are progressing according to quality standards, SOPs, and/or other guidelines to fulfill local regulations as applicable.

• Set up and use initiative plan as a management tool to record, measure and manage progress.

• Proactively communicate with the SDO / Business Partner team ensuring they have all the information required on progress and status (risk analyses, contingency plans, technical information, significant changes of any kind, etc.)

• Work with BP’s / SDO internal team and QM to oversee the development, review, approval and implementation of any controlled processes developed on an initiative as required.

Communication

• Attend 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 including significant changes in resourcing, scope of work and timelines.

• Lead regular meetings/calls with client for SD-study components if required to ensure they are fully informed of initiative progress, pro-active decisions / solutions and how the initiative objectives are being achieved.

• Lead efforts in communication, escalation and support of the initiative across leadership of business partners and SDO as required.

• Ensure multiple stakeholders can easily access information that communicates status with clarity.

• Support key linking efforts in the training and implementation of initiative across the organization, understanding and leveraging the supportive capabilities within the organization as necessary.

Relationship Management

• Develop and maintain working relationships with groups not limited to Business Partners, Initiative team personnel, RWE and SDO functional units, Quality Management, Solutions Consulting, Data privacy, Legal & Risk Management, Leaders of internal businesses SDO is supporting, Vendors both data & technology.

Represent Parexel

• Present on behalf of Parexel at key events.

Desired skills, experience, and education:

• Bachelors’ degree in life science as a minimum.

• Fluent English.

• Late-phase / RWE/ RWD - oriented clinical research experience in both interventional and observational study contexts with significant global project management experience as project manager or clinical leader or equivalent.

• Experience in developing and delivering operational models in clinical research.

• Potential exposure to and experience in setting up and leading cross functional initiatives.

• Familiarity with the regulatory, data privacy and data security landscape for interventional and non-interventional Real World Evidence projects with and without usage of Real-World Data.

• Organized with excellent oral presentation and written communication skills.

• Strong customer focus (internal and external)

• Experienced in technical and operational project planning and management.