JOB DESCRIPTION

Summary/Objective

This position is responsible for managing the delivery and execution of all technical aspects of Electronic Database Capture (EDC) study build including system components for lab management, randomization, drug supply, coding, and data transfer to the Pharmacovigilance database; validation and maintenance, including configuration of database build and parameters, performing update or migration activities for ongoing clinical studies, database revisions, and timely resolution of technical issues related to the conduct and closeout of clinical studies. The Database Programmer works collaboratively with Clinical Data Management and multiple functional groups to complete programming tasks per agreed upon timelines.
Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Serve as a primary technical liaison and subject matter expert (SME) on all data capture components used for Quark studies for internal/external users and partners
  • Provide database build projections to DM/PM Lead for study timeline
  • Use Agile development to program/configure eCRFs according to study team requirements using CDISC principles and standards, and to program edit checks, derivations, and in-system reports – reaching out to cross-functional team members and end users to develop requirements and solutions
  • Train team to conduct and document validation and testing, including Unit Testing and UAT of all system components
  • Create annotated case report forms and end of study media
  • Lead conduct of database and dictionary upgrades
  • Design, review, and maintain electronic data and integration specifications
  • Maintain appropriate technical and study documentation
  • Troubleshoot and correct found issues in all data capture components
  • Act as administrator for all data capture components Review database, edit check, integration, and report specifications and provide input
  • Ensure compliance with applicable regulatory requirements for data capture and storage, company SOPs and study specific procedures
  • Provide accurate and timely answers to technical questions from peers and clients
  • Effectively communicate with various levels of personnel and keep relevant parties informed
  • Participate in process development initiatives impacting Data Management and systems
  • Provide training to users on EDC system use
  • Review and query data according to study requirements
  • May provide mentorship to 1-3 programmers and Data Managers
  • Perform other duties as assigned

 

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to talk or hear. This is largely a sedentary role; however, some filing is required; it would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.

Position Type/Expected Hours of Work

This is a full-time position. The typical workweek is five eight-hour days, Monday through Friday. Occasional evening and weekend work may be required as job duties demand.

Travel

Minimal travel is expected for this position.

Required Education and Experience

  • Typically requires a Bachelor’s degree in statistics, computer science, biostatistics, mathematics or related field
  • 5 years database design and edit check programming
  • 1-2 years of experience with data management tasks
  • Experience as a RAVE Study Builder a plus
  • Experience with EDC integration capabilities such as IRT, drug supply, coding, lab management, CTMS, and transfer to Pharmacovigilance database preferred.
  • Experience with external data acquisition management and upload preferred
  • Excellent problem-solving skills
  • Demonstrated strong attention to detail
  • Basic knowledge of FDA/ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines, the software development lifecycle and 21 CRF Part 11 and other FDA regulations
  • Experience with pharmaceutical industry data standards, such as CDISC/SDTM and ADaM data models

Additional Eligibility Qualifications

  1. Computer proficiency and technical aptitude with the ability to use Microsoft products.
  2. Proven ability to work effectively in a team environment with associates. Capability of effective planning and priority setting. Ability to manage several complex projects simultaneously while working under pressure to meet deadlines.
  3. Excellent communication and organization skills.

AAP/EEO Statement

Equal Employment Opportunity Employer

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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