• We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with. 

Overview

The Senior Principal Clinical Database Programmer provides support to the Data Management Project Manager and other study team members. Performs clinical database configuration / programming and database report development activities throughout the course of the study. This includes oversight of database build, data transfers, creation of system-to-system integrations, and generation of datasets for interim and final data analysis activities.

Responsibilities

• Responsible for timely, complete, and accurate database project deliverables within the data management scope of services
• Develop draft study database using sponsor protocol and standards (if applicable) and existing Lexitas templates
• Implement post-production changes necessitated by protocol amendments or program changes following database go-live based on documented post-production change documentation
• Assist in the facilitation of database user acceptance testing
• Assist in the facilitation of database validation
• Oversee issuance of queries and review query responses
• Interact with internal study team members on database development and maintenance activities
• Participate in client team meetings (as needed) as a technical resource with respect to database development and maintenance activities
• Program randomization schemes if applicable

Requirements

Education: Bachelor's degree or equivalent combination of education and experience. Master's degree preferred

Experience:

• 4+ years of hands-on clinical database programming/configuration experience, preferably in a CRO setting 
• Knowledge of Good Clinical Practices (GCP) and Good Clinical Data Management Practices (GCDMP) 
• Relevant clinical database development experience inclusive of technical experience within and outside of Data Management 
• Experience with one or more commercial EDC platforms (Merative Zelta, IBM Clinical Development, Medrio, MedNet, Medidata RAVE, Datatrak). Experience in IBM Clinical Development is preferred 
• Competent computer skills including MS Office Suite 
• Experience with SAS a plus 
• Experience with SQL a plus 
• Experience with CDISC data standards a plus 

Skills:

• Customer service oriented
• Demonstrated good communication skills (written and verbal)
• Attention to detail
• Manner of interactions demonstrates an understanding of the value of developing positive relationships
• Ability to resolve routine problems and elevate issues appropriately
• Ability to work in a fast-paced environment that requires effective multi-tasking and ability to easily adapt to changing priorities
• Works well as part of a dynamic project team, actively supporting other team members
• Ability to learn new things and assist others

Physical Requirements

Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.