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Data Manager II/III

Data Manager II/III

ID 
2018-1126
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 Data Manager II/III collaborates with various departments on the design, documentation, testing and implementation of clinical data studies.  Develops systems for organizing data to analyze, identify and report trends.  Analyzes the interrelationships of data and defines logical aspects of data sets.  Prepares reports of clinical trial studies for internal validation and cross validation studies.  May evaluate and resolve issues regarding contents of reports.

 

Responsibilities and Job Duties

  • Reviewing protocols
  • Designing Case Report Forms
  • Developing edit checks
  • Creating and maintaining data management plans
  • Testing EDC databases
  • Querying clinical sites for data cleaning purposes
  • Validating SAS programming against the EDC database
  • Collaborating with various departments on the design, documentation, testing and implementation of clinical data studies
  • Writing SOPs and contributing to the improvement of Data Management processes
  • Maintaining Data Management timelines and metrics

Qualifications

Education & Experience

 

Data Manager II

  • Bachelor’s degree in the health sciences disciplines or a related field of study and a minimum of four (4) years of experience in the data management of clinical trials OR high school diploma (or equivalent) and a minimum of six (6) years of experience in the data management of clinical trial
  • At least two (2) years of experience with EDC technology (ex:  RAVE, INFORM)
  • Experienced in all stages of a clinical trials within Data Management

Data Manager III

  • Bachelor’s degree in the health sciences disciplines or a related field of study and a minimum of six (6) years of experience in the data management of clinical trials OR high school diploma (or equivalent) and a minimum of eight (8) years of experience in the data management of clinical trial
  • At least four (4) years of experience with EDC technology (ex:  RAVE, INFORM)
  • Experienced in all stages of a clinical trials within Data Management

 

Knowledge, Skills and Abilities

  • Knowledge of the clinical trial process and how data management supports that process
  • Current understanding of GCP and regulatory requirements as they relate to data management systems and activities; demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)
  • Ability to work independently and collaboratively in a team-based environment
  • Must be proficient in MSOffice (Word, PowerPoint, Excel) and other relevant software
  • Ensures CRO compliance with applicable DM SOPs, safety data standards, and regulatory guidance
  • Demonstrated ability to support multiple assignments with challenging timelines and work under pressure
  • Able to effectively manage multiple assignments and adapt flexibly to changing priorities.
  • Able to produce robust timelines and action plans, regularly review and follow up on progress and take decisive action in terms of follow up activities with local and global trial/project teams. Ensures work is completed effectively.
  • Ensures all tasks are carried out in accordance with respective applicable MacroGenics’ Standard Operating Procedures (SOPs), regulatory guidelines and working instructions.
  • Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with MacroGenics’ Living Values.

 Preferred Qualifications

  • Prior experience with oncology clinical trials
  • Data Manager Certification strongly preferred

 

Supervisory Responsibilities

None

 

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.

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