Boston Categories:
Study Design Analyst PHT
THIS JOB HAS EXPIRED
Department: Technical OperationsReports to: Team Leader, Study Design
Location: Boston
The Study Design Analyst is responsible for delivering the highest quality ePRO Trial design, development, and consulting to our pharmaceutical/biotechnology industry clients. The Study Design Analyst will be aligned with one or more project teams as well as interface with clients.
Position Responsibilities:
ePRO Trial Design
Function as ePRO Trial Design Subject Matter Expert to advise internal and external clients on ePRO Trial design, configuration and data structures to meet clinical trial goals and objectives and to optimize the benefits of collecting eSource data.
Assist with the gathering and interpretation of user, functional and system requirements for ePRO Trials
Translate project-specific requirements into ePRO Trial designs to optimize data capture and eSource repository using PHT?s ePRO Trial design applications
Develop, document and maintain PHT ePRO Trial Design Best Practices to leverage PHT and industry ePRO data capture, management and delivery best practices
Ensure consistency between ePRO Trial data capture, delivery and structures to meet client requirements
Work with Project Manager to establish or refine scope definition and to provide work effort/duration estimates throughout the lifecycle of the ePRO Trial
Sales
Attend client meetings with Sales to represent the ePRO Trial Design function and describe design best practices
Product and Process Development
Provide feedback with regard to product functionality and share with Product Development group
Assist in the evaluation of new product features
Education Minimum: BS, BA or equivalent; Masters Degree in science/healthcare-related field a plus.
Required Skills and Experience:
Minimum of three years of experience in the execution of clinical trials or equivalent, preferably with two years of clinical data management experience
Ability to understand and interpret clinical trial documentation such as protocols, questionnaires and other data collection instruments, and clinical data models
Knowledgeable in clinical trial data management and database structure and design
Demonstrated experience in interpretation of client requirements to prepare and document design specifications
Proven experience in client relations and interactions with clients at all levels
Familiarity with FDA regulatory processes, clinical research processes and CDISC standards
Self directed - comfortable working in a fast-paced environment
Ability to manage multiple project tasks and deliverables
Proven problem-solving skills and attention to detail
Excellent presentation, communication (written and oral) and negotiation skills
Ability to travel up to 25%
Tasks:
Reviews the SOW (Statement Of Work) and Study Protocol
Participates in Sales/Science Handoff Meetings
Participates in Kickoff Meetings with clients teams
Assist in the development of design-related materials for Client Meetings
Assist in the gathering Client Requirements and in the preparation of the Requirements Document
Creates and maintains design specifications and ensures that specifications and study documentation is maintained correctly in PHT document control system
Participates in internal (PHT) Study Project Team meetings
Prepares the eClinical Trial designs and utilizes PHT applications ePRO Designer and Study Designer to build the eClinical Trial
Participates in requirements and design meetings with the client teams
Assists the Project Manager in the development of the preliminary scope definition
Provides effort/duration estimates regarding ePRO Trial design throughout lifecycle of project
PHT-Specific Training:
Core LogPad/StudyPad and StudyWorks functionality
SOP0401 eClinical Trial Configuration & Management
SOP0403 eClinical Trial Deployment and Execution
ePro Designer
Study Designer
Software Development Lifecycle
Issue Escalation and Resolution Process
General Business Training:
Quality Management
?How to gather and write a Requirements Specifications?
?How to Conduct Effective Meetings?
Visio
| Location: | Boston, MA United States |
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THIS JOB HAS EXPIRED
PHT
Investors: Boston Millennia PartnersAll Jobs: at PHT
| Web Site: | www.phtcorp.com |
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| Headquarters: | 500 Rutherford Avenue Charlestown, MA 02129 United States |
| Industry: | Software |
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