Senior Director, Clinical Solution Architecture

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POST DATE 9/16/2017
END DATE 11/29/2017


Waltham, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Want to know why we were rated as one of America's \\"Best Employers\\" by Forbes Magazine? We offer a flexible work environment, ability to work with leading experts in our industry and a chance for career advancement, and that is just a few of our perks.

We currently have a need for a Senior Technical Director for our Solution Architecture team. For assigned accounts, you will have global responsibility for the design, and the accountability for the implementation and ongoing production support, of comprehensive solutions (process & technology) to meet the specific needs of the accounts.

The focus of all solutions is to support the profitability of the PAREXEL Informatics & Phase II/III & Peri/Post Approval service lines, to ensure quality delivery, and aid new business acquisition.

The Senior Director provides global strategic leadership for the most challenging accounts within the clinical trial technology space, taking on the most complex assignments in a consulting role. Typically they will have overall accountability for more than one large strategic account, all the way from pre-sales, helping to win the contract, through to post-award, delivering and supporting the solutions.

This position can either be office based in one of our locations or home based.

Key Accountabilities:

- Drive NBA leveraging the benefits of technology, using our systems as a differentiator, and custom designing solutions to attract clients.
- Identify, design and program manage process & technology solutions through to production implementation and support, of high value process & technology solutions without direct supervision.
- Drives the use of standard solutions wherever possible
- Maintain awareness of technologies and respective roadmaps that are used and/or available for use within Clinical Research Services, Information technology, Perceptive Informatics and other external vendors (Oracle, Medidata, etc.) and related integration strategy.
- Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL WSOP and client and project specific procedure
- Understand technical and clinical processes and provide integrated solutions.
- Understand technical data standards (CDISC, HL7, ISO, PAREXEL, Client) and how they can be used to support technology integration and increase efficiency in programmingQualificationsWhat do you need?


- Technical and data standard experience
- Experience of Enterprise Architecture and Systems Integration, with evidence of implementation
- Experience in clinical trial systems (CTMS, EDMS, EDC, IVRS, reporting tools, ..)
- Develop detailed awareness of CRS, PI, external vendor software and tools with practical knowledge of how these applications could fit together through a data flow and the inputs and output that are requirement to feed each application.
- Demonstrated adeptness in learning new systems and function in an evolving technical environment.
- Awareness/experience in the needs and use of data standards in clinical trial environment; if possible knowledge/experience of data standards such as CDISC and HL7
- Communication skills
- Able to present complex material to a wide audience in an easily digestible fashion with confidence and clarity
- Excellent verbal and written communication skills.
- Strong customer focus (internal and external).
- Coordinating global virtual teams around technology integration and data standards
- Proven ability to manage independently competing priorities with attention to detail.
- Experience in (technical) project management, planning, budget
- Ability to motivate and work effectively with virtual teams within different cultural environments.
- Ability to negotiate and influence in order to achieve results.
- Business process
- Good understanding and experience of clinical trial processes
- Experience in business process redesign and process improvement
- Knowledge of SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
- Financial awareness business case definition
- Experienced in budgets and cost evaluation of technology solution
- Ability to transform benefits and costs into a business case with quantified ROI
- General
- Commitment to quality and quality management.
- Commitment to refine quality processes.
- Tenacity to work in an innovative environment.
- Flexibility to change.

- Bachelor s degree preferably around computer sciences - and / or equivalent experience.
Language Skills

- Excellent English written and oral communication skills.
Minimum Work Experience
- 12 years professional experience minimum
- Enterprise Architecture experience required, or similar systems integration experience
- Worked in the field of Clinical Studies, understanding clinical trial processes
- Technical project management experience of benefit in the eClinical/Technology Integration area
- Proven record of leading a team and leading complex scope projects in clinical research area and/or IT integration
- Experience with external data standards organization (CDISC, HL7) is a plus

EEO DisclaimerPAREXEL 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.