Clinical Solutions Consultant
OmniComm Systems, Inc. - Monmouth Junction, NJ

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Company Description:
OmniComm Systems, Inc. is a fast-growing, global eClinical software and services company dedicated to helping woldwide pharmaceutical, biotechnology and medical device organizations maximize the value of their clinical research investments through the use of innovative software and progressive technologies. Our Electronic Data Capture (EDC) and eClinical technologies have been used in over 4,000 clinical trials around the globe.

OmniComm Transformation Services helps organizations transform their clinical business through innovation, integration, and process optimization activities. OmniComm Transformation Services is seeking outstanding individuals with versatile professional services and technology backgrounds, a passion for delivery excellence, and a track record of success.

Job Description:
POSITION SUMMARY

The Clinical Solutions Consultant is responsible for designing, proposing, and delivering both business and technology solutions to customers in the pharmaceutical and life sciences industry. The Clinical Solutions Consultant will develop proposals, define deliverables and timelines, and estimate project delivery efforts. This individual also assists in the development of project scope estimates and overall project delivery quality practices. The Clinical Solutions Consultant has a diverse background delivering technology, strategy, and business process improvement projects to the clinical research community.

PERSONAL QUALITIES

The Clinical Solutions Consultant possesses broad technology skills including an understanding of systems and application architectures, and other software components. The consultant has the following personal qualities: The ability to translate a client's general specification into specific requirements, proposals, design deliverables and solutions; Extremely adept at handling multiple priorities and projects; Strong customer-facing communication, listening and understanding skills; A proactive, responsible and entrepreneurial leader as well as an individual contributor; The ability to deliver high quality documents, presentations, proposals and other project deliverables.

RESPONSIBILITIES

Develop project estimates, proposals and statements of work for both large and small fixed price project engagements.
Create presentations that describe project approach and capabilities.
Develop application and solution architecture diagrams, as well as business process models.
Create project deliverables such as requirements and requirements documentation, scope documents, design documents, validation documents, storyboards, and process flow diagrams.

SKILLS NEEDED

Experience working with Life Sciences organizations involved in the conduct of clinical trials.
Knowledge and understanding of technologies, regulations, and processes used in managing, conducting, and supporting clinical trials.
Knowledge, experience with eClinical technologies such as Electronic Data Capture, Clinical Trials Management Systems, Adverse Events Reporting, Clinical Portal, IVRS, etc.
Demonstrated ability to understand and anticipate the needs of the customer and to provide solutions and recommendations that work in the real world.
Strong communications, writing, and analytical skillsets.
Understanding the industry standard architecture components necessary to support implementation activity of clinical systems.
Understanding of industry methodologies, delivery, and pricing approaches.
Demonstration of interpersonal skills necessary to maintain positive relationships with clients and all users.
Ability to establish priorities, can work independently, and can proceed with objectives without supervision.
Adept at architecting business and technology solutions and shepherding the implementation of both small and mid-size service engagements.
Average Travel Time - 20% - 30%

QUALIFICATIONS NEEDED

College Degree with a major in Information Technology, Computer Science, Biology or similar.
Has a strong background with pharmaceutical or clinical business processes and technologies, strong communication skills, and professional services background.
Knowledge of industry regulatory and IT standards including computer systems validation, 21 CFR Part 11, CDISC, MedDRA, WHODRUG, E2B, and HL7.
5-10 years of experience with related technology, professional services, and/or life sciences industry expertise.

LOCATION

This position will report into OmniComm Systems Solutions Center in Monmouth Junction, NJ.

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About this company
OmniComm Systems, Inc. provides Web-based Electronic Data Capture (EDC) software and services that streamline the clinical research process....