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Database Developer II

Database Developer II

ID 
2018-1228
Category 
Biostatistics, Data Managment & Programming
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The Database Developer II is responsible for the design, development, implementation, modification, and support of clinical trial databases in support of MacroGenics clinical trials. This entails designing and developing electronic Case Report Forms (eCRFs), related edit checks, other database objects and documentation to meet project timelines. The Database Developer II will also participate in eCRF Standardization efforts, protocol reviews, and clinical study team meetings where they will interact with other functional areas.

 

Responsibilities and Job Duties

  • Work independently to efficiently Identify, design, develop, document, and maintain the Rave study database objects used to capture clinical data for a trial, i.e. Forms, Folders, Matrixes, Dictionaries, edit checks, and custom functions in accordance with industry and NGO standards and protocol/amendment specifications.
  • Review clinical trial protocol visit and assessment schedule of events to identify potential database design challenges for the EDC system. Review protocols and amendments and identify any additional development necessary to display forms appropriately to ensure the right form at the right visit.
  • Obtain feedback from study teams and ensure that the eCRF design meets the needs of the study team.
  • Program edit checks defined in the study Data Validation Specification to automate the data cleaning process to minimize errors from manual reviews and create greater efficiency in the process.
  • Assist with the development of, and the review of documents associated with clinical trial databases such as Data Validation Plans, Data Management Plans, CRF Completion Guidelines and Protocols/Protocol Amendments. Understand the interrelationships between the plans and protocols and their impact and make recommendations to maximize the accuracy and consistency of the database data.
  • Provide technical and administrative support for users of the clinical database. Assist with investigating and resolving technical issues for MacroGenics’ users or when not possible escalate problems to Medidata. Also manage user accounts and privileges, report access and certain advanced features such as report builder software.    
  • Identify, develop, and document standards for eCRFs and related edit checks to facilitate greater efficiency when developing the clinical studies.

Qualifications

Education & Other Credentials

  • Associate of Arts/Sciences degree

 

Experience

  • At least four years of experience in Clinical Development in the pharmaceutical or biotechnology industries and at least 18 months of experience designing EDC clinical study databases.

 

Knowledge, Skills and Abilities

  • Must possess ability to handle multiple priorities in a fast-paced environment.
  • Must possess good written and verbal communications skills.
  • Must be proficient in the use of Microsoft Office software (word processing, email, spreadsheet).
  • Must also be able and willing to support occasional projects outside normal business hours due to customer impact.
  • Ability to seek solutions at the root level of problems
  • Detail oriented
  • Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner.

               

Supervisory Responsibilities

No

 

Preferred Qualifications

  • Experience with Medidata Rave/RaveX EDC
  • Experience programming in the C# programming language.

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.