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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.

Scientific Data Solutions Architect & Program Director

Job ID 67333BR USA - Any Region - Home Based
Parexel's Scientific Data Organization (SDO) provides our clients with a wealth of real world data which helps drive their development plans and strategies, and the team is growing! If you have CRO and data experience, love presenting to clients, are a self-starter, have a passion for problem solving, and are familiar with RWD, we would love to connect!

The primary role the Scientific Data Solutions Architect & Program 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. He/she 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.

General areas of responsibility: oversight and management of scientific data solution development and scientific data project start-up, implementation and closeout, inclusive of milestone planning, resourcing tracking, and ensuring that the scientific data aspects of a project are progressing according to contractual requirements, governing SOPs, data and quality standards, and applicable regulation.

• 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

Accountability Supporting Activities
• 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

SDO Project Management
• Manage the set-up of the SD-enabled components of project delivery; oversee request for any SD-required resources; review proposed team members for suitability and manage any project team changes throughout the project
• Work with the CRS / PAC or MSS Project Manager (if assigned) to incorporate SD-specific project plan elements into project planning documents ie. Roles and Responsibilities, WBS, Project Plan, Communication Plan, Risk Analysis, and training
• Review initial SD budget components provided by Project Financial Analyst
• 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 SD-project elements are progressing according to quality standards, SOPs, and/or other guidelines to fulfill local regulations and projects are completed within budget, on schedule and according to contract specifications
• Use project plan as a management tool to record, measure and manage progress
• Proactively take action to maintain SD-project deliverables

Qualifications

Communication
• Attend team meetings on a regular basis with project team to ensure SD project objectives are met; ensure the on-going communication to team members of the SD scope of work, timeline and project goals, technical information, and input from client throughout the project 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 project progress, pro-active decisions / solutions and how the project objectives are being achieved.

Relationship Management
• Develop and maintain working relationships with Scientific Lead, Project team personnel, SDO functional units, Global Data Operations, Quality Management, Solutions Consulting, Data privacy, Legal & Risk Management, Leaders of internal businesses SDO is supporting, and clients.

Compliance
• Ensure compliance with operating standards, policies, regulations, SOPs, privacy and data security standards
• Represent Parexel in professional societies
• Present on behalf of Parexel at key events

Skills:
• Organized with excellent oral presentation and written 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
• Senior: advanced ability to work independently

Knowledge and Experience:
• 12-15 years of 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; previous experience with wearables/sensors is a PLUS
• 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 Scientific Data, Commercial and Operational (functional) organizations
• Highly effective in eliciting Sponsor/client confidence and trust in Parexel solutions and services
• 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


Education:
• Bachelors’ degree required
• Advanced degree preferred (Masters’ degree in life sciences, epidemiology, biostatistics, public health or equivalent)

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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