Clinical Data Management-Study Designer-Fort

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Accenture?s Services workforce is a dedicated team of people who work on outsourcing engagements. These are long-term partnerships with clients for whom we manage and provide increasingly specialized business operations, such as finance and accounting, IT, applications development and maintenance, help desk services, and HR.  We not only maintain key business functions for clients, we constantly seek to improve them to help our clients move ahead of the competition.

 

The Services workforce is made up of four groups: Client Operations, Project Based, Delivery Centers and BPO Businesses.  Most of our people in Services are based long-term at a client location, an Accenture Delivery Center or, in some cases, an Accenture office.

 

Job Description

 

The Study Designer manages the end to end delivery of EDC study databases to ensure that they are developed in accordance with standard business processes, meet client requirements per the protocol and adhere to Good Clinical Data Management Practices. Study Designers work with US resources including the protocol development team members, Project Managers and other functional departments during the initial specification and final UAT of EDC study databases for clinical studies and custom reports.  Study Designers also work with India resources such as the Study Builders during the development and QC testing of EDC study databases and clinical reports for clinical studies.

 

Responsibilities:Serve as a project point of contact for Study Build resources, QC Specialists, and Report Developers providing detailed study setup and configuration knowledge and expertise. Work with protocol development teams in translation of customer needs from the protocol to the EDC study database ensuring that the specifications are within the bounds of the actual system capabilities/limitations. Work directly with Project Manager and/or the protocol development teams to prepare, adapt, or agree on all specifications provided by the protocol development team Ensure that offshore functions are aligned and meet Project Management timelines and deliverables Assist in the scheduling of offshore resources and ensure timely completion of deliverables Review study database and edit check requirements from clients, determine whether complex or simple, and estimate work effort Provide written regular status reports

Requirements:Knowledge of clinical trial processes, specifically as they related to data collection, management, and preparation for statistical analysis Ability to understand data management plans/customer specifications for data entry screens, edit checks, and custom reports. Ability to understand protocols and identify data collection needs for clinical trials Excellent organizational and time management skills Excellent verbal and written communication skills. Ability to think logically to solve complex problems Solid analytical and technical skills Ability to handle multiple projects with rapidly changing priorities and deadlines Self-motivating, able to assume responsibility and work autonomously in a professional manner Total commitment to quality and attention to detail Knowledge of Computer usage in a web-based environment Strong collaboration and team building skills. Ability to lead team, provide feedback and mentoring

 

 

Qualifications

 4 year undergraduate degree strongly preferred 3 years of experience working with clinical trials in a data management-related role, or equivalent combination of education and experience


Our people are our most important asset and we invest considerable resources to provide on-going training that builds and extends professional, technical and management skills in all areas. Your learning program will be determined by the requirements of your specific role but will usually involve specialized skills as well as personal and leadership development. You will work with your manager to determine what skills you need and how to build them.

 

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Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.

 

Applicants for employment in the

U.S. must possess work authorization which does not require sponsorship by the employer for a visa.

 

We are an Equal Opportunity Employer.