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Principal RWD Solution Lead

Parexel International Corporation

United Kingdom, Remote

The primary role the RWD Solutions Director is to understand client research objectives and requirements in order to lead a multidisciplinary project team in the development and implementation delivery of scientific data-enabled solutions and services to SDO internal customers and their Sponsor-clients. RWD Solutions Director will partner with Scientific Leads, SDO internal clients, SDO data asset management and technologists, Parexel and Client Therapeutic Area and Medical experts, Biostatisticians, Epidemiologists, and Medical Informaticists to develop and implement study designs that leverage the use of scientific data, inclusive of operational delivery model and data flow development and generation of data access and analysis requirements (data selection, collection, curation) with corresponding technology selections required to deliver in alignment with Sponsor research objectives.

Key contributor to study design
Partners with internal clients, data asset management and technology, medical, statistics on project design, analysis requirements and operational models required for intended use of data
Scientific data-enabled solution development Understand scientific data (SD) study requirements followed by the design, planning, implementation and management of those scientific-data enabled aspects of study delivery for SDO internal customers / project teams.
Contract management Review the project proposal/budget (presales) and project contract/exhibits (post ward) to ensure SDO provided services are appropriately scoped and budgeted. Manage these aspects of project scope / changes in scope in concern with the CRS / PAC or MSS project lead through-out the duration of the project.
Manage the set-up of the SD-enabled components of project delivery; oversee request for any SD-required resources.
Work with the CRS / PAC or MSS Project Manager (if assigned) to incorporate SD-specific project plan elements into project planning documents where appropriate (Roles and Responsibilities, WBS, Project Plan, Communication Plan, Risk Analysis, and training.
Review initial SD 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 SD-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
Ensure that SDO-specific project management tools are in place (e.g. resourcing tracker, etc.)
Lead the SD-project components such that they are completed within budget, schedule and according to contract specifications.
Ensure that SD-project elements are progressing according to quality standards, SOPs, and/or other guidelines to fulfill local regulations.
Use project plan as a management tool to record, measure and manage progress.
Proactively take action where required to maintain SD-project deliverables using management information provided by the Project Manager and Project Financial Analyst.
Pro-actively communicate with the client ensuring the client has all the information required on progress and status.
Oversee all administrative closeout procedures are completed for SD project components, according to Project Closeout Checklist.
Ensure SD project documentation is archived as specified the 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.
Lead regular meetings/calls with client for SD-study components if required to ensure they are fully informed of project progress, pro-active decisions / solutions and how the project objectives are being achieved.

Skills:

Organized with excellent communication skills.
Strong customer focus (internal and external)
Experienced in technical and operational project management, planning and budgeting.
Ability to manage multiple projects.
Analytical and problem-solving skills.
Ability to lead a decentralized team.
Ability to set and manage priorities.
Excellent interpersonal skills.
Strong tactical skills.
Strategic and long-term project planning

Knowledge and Experience:

Extensive late-phase / RWE-oriented clinical research experience in both interventional and observational study contexts, with at least 8-10 years of global project management experience in roles of increasing seniority/accountability.
In depth understanding of scientific data application across the clinical research spectrum inclusive of corresponding data access/acquisition requirements, study delivery processes, technology selections and project team resource configurations.
Proven ability to efficiently and effectively assess a Sponsor’s evidence generation needs and assemble a multi-disciplinary team capable of creating leading and innovative research solutions which leverage scientific data in the service of Sponsor requirements.
Demonstrated ability to apply scientific 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-SBU stakeholders within Parexel's Scientific Data, Commercial and Operational (functional) organizations.
Experienced in budgeting and cost evaluation of scientific data processes and technologies
Working knowledge of scientific 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.
Familiarity with data and privacy regulation and policy around the world which impacts the utilization of real-world data across the clinical research spectrum.

Job posted: 2023-05-11

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