Principal RWD Solution Leader

When our values align, there's no limit to what we can achieve.
 

Picture Yourself At Parexel:

The primary role of the Principal RWD Solutions Leader (RWDSL) is to bring their solution-focused expertise, training and experience to review, recommend, develop, and implement real-world data-enabled solutions for SDO internal and external customers to meet client research objectives across the range of SDO offerings. The Principal RWD Solutions Leader will partner with a multidisciplinary project team, consisting of scientific leads, SDO internal clients, SDO data strategists and technologists, Parexel and client therapeutic area and medical experts, biostatisticians, epidemiologists, and medical informatics to leverage the use of Real-World Data (RWD) and facilitate diverse study designs and requirements. The role will support operational delivery model and data flow development. In collaboration with SDO data strategists and technologists and in consideration of project data access / analysis requirements, the Principal RWD Solutions Leader will evaluate and propose suitable technology and secondary data sources to address client needs. The Principal RWD Solutions Leader can competently and independently lead large, complex projects and/or programs with little guidance. Principal RWDSLs may act as a mentor for RWDS Associates, RWDSLs and Snr RWDSLs. The Principal RWDSL will, where necessary, take on specific RWD solution SME role and / or Account alignment. Additionally, the Principal RWDSL can lead commercial engagements for SDO independently, with high degrees of customization, innovation, and importance. The Principal RWDSL will also be expected to work to improve SDO capabilities through proactive engagements with the SDO core solutions and core capabilities teams, including active ownership of specific initiatives where necessary. 

Lead proposal development and bid pursuit meetings on behalf of the SDO team.

Oversight of RWD solution development and RWD project start-up, implementation, and closeout. This includes milestone planning and tracking, resource tracking, and provision of RWD deliverables in accordance with contractual requirements, governing SOPs / regulations, and data / quality standards, SDO project scope management.

Partner with internal business partners, SDO data strategists, SDO technology, Medical Directors, and statisticians to facilitate refinement of study design, analysis and operational model requirements.

What You'll Do At Parexel:

Real-world data-enabled solution development 

Demonstrate high understanding of RWD solution requests, study requirements and design, planning, implementation and management of those RWD-enabled aspects of project and study delivery for SDO internal and external customers.

Principals will be expected to lead RWD projects of high complexity independently. 

Bid Pursuit Meetings/ RFPs - RFIs   

Lead SDO Participation in and preparation for RFPs / RFIs, to ensure SDO-provided services are appropriately scoped and budgeted. Also consider pricing/discounts during proposal stage. 

Lead SDO Participation in and preparation for study or program-level Bid Pursuit Meetings.

Represent at expert level SDO's RWD, technical and operational expertise and capabilities, and tailor to meet sponsor's specific needs.

Present with confidence and as a cohesive Parexel team with other functions.

SDO Project Management  

Manage the set-up of the RWD-enabled components of project delivery; oversee requests for any RWD-required resources; review proposed team members for suitability and manage any project team changes throughout the duration of the project.

Work with the Project Leader to incorporate RWD-specific project plan elements into project planning documents where appropriate. 

Review initial RWD budget components provided by Project Financial Analyst, request any project specific adaptations.

Review and finalize project metrics impacted by SDO delivery with Project Financial Analyst and Project Manager.

Lead the RWD-centric discussions during internal and client kick-off meetings, ensuring the SDO scope of the project is well understood by the Sponsor, project team and all supporting functions. 

Lead the RWD-project components such that they are completed within budget, schedule and according to contract specifications.

Ensure that RWD-project elements are progressing according to quality standards. 

Proactively communicate with the client, ensuring the client has all the information required on progress and status (risk analyses, contingency plans, technical information, significant changes of any kind, etc.) of the RWD-enabled aspects of project delivery; provide proactive decisions / solutions regarding the RWD objectives. 

Verify all administrative closeout procedures are completed for RWD project components, according to the Project Closeout Checklist.

Ensure RWD project documentation is archived as specified by the contract.

Participate in end of project meeting to ensure lessons learned information is documented and passed on via appropriate channels and within the SDO. 

Relationship Management   

Develop and maintain working relationships with Scientific Leads, project team, SDO functional units, Global Data Operations, Quality Management, Solutions Consulting, Data Privacy, Legal & Risk Management, additional internal business partners SDO is supporting, and clients with support as needed. 

Compliance   

Ensure compliance with policies, regulations, SOPs, and privacy / data security standards. 

Represent Parexel  

Potential for limited representation of SDO and Parexel in professional societies, if requested and under direction.

Vendor oversight  

In limited capacity and under direction, support the assessment new RWD / technical vendors, maintain key vendor contact with support as required. Ensure that vendors are fully informed of client RWD requirements and deliverables to meet client timelines. 

Marketing

In limited capacity and under direction, support delivery of appropriate marketing materials to support overarching marketing strategies. 

Ideal candidate will possess:

Bachelor’s degree required - advanced degree (Master’s degree in life sciences, epidemiology, biostatistics, public health or equivalent).

Several years of clinical research experience.

Late-phase / RWE-oriented clinical research experience in both interventional and observational study contexts with significant global project management experience in roles of increasing seniority / accountability.

Experience in study and project solution development 

Potential exposure to and experience in sensor solution environment.

Understanding of real-world data application across the clinical research spectrum, inclusive of corresponding data access / acquisition requirements, study delivery processes, technology selections and project team resource configurations.

Ability to efficiently and effectively assess a Sponsor’s evidence generation needs and assemble a multidisciplinary team capable of creating innovative research solutions which leverage RWD in the service of Sponsor requirements.

Ability to apply real-world data-enabling processes and technologies to support research hypotheses and / or overcome clinical research challenges inherent in any given study design.

Ability to form strong partnerships with a broad range of cross-functional stakeholders within Parexel’s Scientific Data, Commercial and Operational organizations.

Experience in budgeting and cost evaluation.

Knowledge of real-world data and technology environments, including relevant data sources (EMR, claims, registries, health care data bases, etc.), data applications (mHealth, sensors/wearables, specialty labs, genomics, etc.), data flows, data repositories, data security, and associated patient privacy/consent provisions.

Excellent oral presentation and written communication skills

Experienced in technical and operational project management, planning and budgeting.

Ability to manage multiple projects.

Ability to lead a decentralized team.