The candidate is an individual who will facilitate the coordination of the design of all Information Technology Research and Development (R&D) Systems' application solutions and databases for business functions supported by Information Technology (IT).

Directs and supports development of IT solutions that enhance mission-critical business operations.

Works with managed services vendors to facilitate the provision of system services to organization.

This person is responsible for the Clients EPIC system and responsible for outsourced function.

Duties: · Supports the business needs of those users performing clinical trials, including Safety and Pharmacovigilance, PK, Regulatory, Clinical Trial Management systems, LIMS, interaction with Clinical vendors, and the data collected during those processes.

· Manages a team of solutions analysts, consultants, and other application development staff.

· Develops, supports and maintains optimal operation of Information Technology Systems in support of R&D Systems, assuring implementation of best practices.

This includes directing the installation, configuration, design, patching, upgrading, and maintenance.

o Collaborates with Business Integration, Program Support and Infrastructure and Operations to analyze and validate the business needs of project stakeholders.

Applies analytical and problem-solving skills to help support the development process, and to ensure that project deliverables conform to System Development Life Cycle specifications.

Ensures that applications meet business requirements and systems goals, fulfill end-user requirements, and identify and resolve systems issues o Develops and maintains procedures that must be used in the development of all information systems, to ensure compliance with all applicable guidelines, (i.

e., 21 CFR Part 11).

o Plans and coordinates change management processes, assuring required support of application systems necessary for regulatory compliance is maintained.

o Oversees related projects and project portfolio.

· Ensures that new software integration into company systems meets functional requirements, system compliance, and interface specifications.

(Experience with systems integration/implementation a MUST)· Consults with and advises IT executive staff and decision makers in other departments in order to identify, recommend, implement, and support cost-effective technology solutions for all aspects of the organization.

· Establishes all functional policies and procedures for R&D databases and applications, including installation protocols and system access SOPs.

· Analyzes existing operations and make recommendations for the improvement and growth of the R&D enterprise infrastructure and IT systems.

· Negotiates and administers vendor, outsourcer, and consultant contracts and service agreements.

· Provides software architectural expertise, direction, and assistance to Solutions Analysts and other IT roles · Confers with end-users and clients in collaboration with the Business Integration team to ensure comprehensive business requirements are understood prior to development and implementation · Major contributor to the development of the Statement of Work document reflecting the deployment of customer implementation · Coordinates the completion of all Life Cycle documentation associated with the implementation of a R&D computerized system solution · Responsible for the development and execution of a detailed implementation plan · Models business and systems processes based on findings through use case scenarios, workflow diagrams, and data modelsRequirements: · Bachelor's degree in Computer Science, Engineering, Business or a closely related discipline.

5+ years IT experience with the Life Sciences industry.

· Prior direct experience with Research and Development (R&D) Systems (Oracle/SQL, Argus, Trackwise, IMPACT, Clintrial and enterprise level relational databases etc.) for an R&D organization · 3+ years prior experience in a leadership role managing employees and/or contractors.

Will have up to 3 direct contractor reports.

· 3-5 years' experience in software-intensive systems development or related area with experience in developing Web-based technology applications, and an understanding of relational and OLAP principles and architecture (Oracle) · In some cases, a combination of performance, education and related experience may be considered as equivalent to the above requirements provided that the individual processes the knowledge, skills, and abilities to perform the job requirements satisfactorily.

· Experience with the pharmaceutical industry computerized system solutions in general preferred.

· Experience with Clinical Trial Management, Regulatory Submissions, Data Management, Clinical Safety and Quality Management processes and other 3rd party data sources · Project management principles and software development life cycle management experience helpful · Knowledge of global computer system regulatory requirements as they relate to systems development and validation preferred · Analytical and Problem Solving skills · Excellent communication and interpersonal skills to interact with a wide range of individuals in a wide range of situations which usually requires tact, diplomacy, and discretion.

· Ability to multi task, prioritize and escalate tasks appropriately.

· Project Management skills (PMP Certification a plus) · Management skills to drive daily accomplishment of work and relationship management · Strong IT program problem solving and solution skills· Skilled in the use of Relational Databases, Defect Tracking, and Configuration Management.

· Relational/object database implementation & integration.

· Web-based/legacy system / client-server architectures.

· EXCELLENT communication skills and time management skills For immediate consideration please forward resume and cover letter to dmk1 [at] judge [dot] com

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