JOB DESCRIPTION:

Mid-level position responsible for development, infrastructure and support of systems and tools that help maximize efficiency and effectiveness of executing St. Jude Medical Clinical Trials globally.  Assignments may include but are not limited to designing and developing clinical trial databases, developing and supporting technology solutions for clinical trial management, designing data models, conducting code reviews, and maintaining and supporting clinical systems infrastructure. 

Job Duties: List the significant/essential duties, tasks or responsibilities which employees in this position are required to perform.

• Develops complex software solutions to streamline management and execution of clinical trials using technologies such as ASP.NET, PL/SQL, BI Dashboard and BI Publisher via Software Development Life Cycle (SDLC) best practices
• Develops Software Requirements and Design Specifications
• Builds and supports clinical study databases using Oracle Clinical Database Management System based on requirements provided by Clinical Data Analysts utilizing development standards
• Develops error validation functionality to improve user experience and to ensure the integrity of clinical study databases
• Develops custom utilities to streamline Oracle Clinical interfaces to various clinical and non-clinical systems using Oracle PL/SQL and ASP.NET
• Maintains and supports existing applications through development and architecture of new features and enhancements
• Maintains and administers security and access control for the SJM Global Clinical Affairs Organization
• Develops solutions to streamline software configuration/release management to improve software quality and performance
• Maintains and supports infrastructure for all systems and tools supported by Clinical Data Systems, including software installation, configuration and deployment
• Works independently with minimal guidance required
• May lead establishment and improvement of software development standards and practices
• May mentor other team members on development approaches and new technologies
• May lead architecture and design on larger, more complex projects
• May supervise other team members or lead projects
• May assist leadership with project prioritization and development of clinical technology strategy
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications: Describe the minimum education and experience, including knowledge, skills and abilities, required to successfully perform the job.  List any certificates, license, and/or registrations required.

General Qualifications

• Bachelor Degree in Software Engineering, Computer Science, or equivalent
• 6-8 years of development experience with ASP.NET
• 6-8 years of database modeling/design experience using SQL 
• 6-8 years of software infrastructure support, including software configuration and release management
• 1-3 years of leading software architecture and design experience
• Experience with Software Development Lifecycle (SDLC) phases and Rapid Development Frameworks
• Experience with software development design patterns and methodologies including OOAD and MVC
• Experience with HTML5 and JavaScript Libraries such as Knockout, Angular and Kendo UI preferred
• Experience with Mobile Application Development frameworks such as xCode, Android NDK, Xamarin and PhoneGap preferred
• A working familiarity with Microsoft office products including Word, Excel, and Access
• Experience with Unix/Linux (*NIX) platforms
• Basic Windows Desktop Administration experience such as application installation and troubleshooting
• Windows Server Administration experience including installation of server roles, log management and troubleshooting
• Knowledge of Windows Server Security practices in an enterprise environment including computer network authenticating protocols such as Kerberos
• Experience working with active directory in either a development or administrative environment
• Experience integrating software with enterprise level systems
• Experience mentoring and teaching other team members
• Experience building clinical trial databases using Oracle Clinical or equivalent preferred
• Experience building/customizing Clinical Trial Management Applications preferred
• Basic understanding of Clinical Trial Management Process preferred
• Basic understanding of human physiology or any prior involvement with medical field preferred
• Experience working in a broader enterprise/cross-division business unit model preferred
• Ability to work in a highly matrixed and geographically diverse business environment
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and meets deadlines in timely manner
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to travel up to 5%

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Clinical Affairs / Statistics

     

DIVISION:

MD Medical Devices

        

LOCATION:

India > Gurgaon : BPTP Park Centra

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)