Job Description

Study Builder I

Location:

BostonMassachusetts

Date Posted:

3/14/2022

Employment Type:

Permanent

Recruiter:

Mohamed Barami

Recruiter Email:

mo.barami@avidtr.com

Job ID:

JN -032022-14969

Job Description

Study Builder I is primarily responsible for database design, setup, and maintenance of assigned clinical trials/projects in Medidata Rave.

Responsibilities:
  • Designs and develops electronic case report forms (eCRFs) to meet the data collection requirements of oncology protocols in accordance with our clients standards and guidelines including CDASH/SDTM/CDISC standards published by NCI for use in NCTN studies
  • Works closely with Data Management and Statistical staff to develop and validate eCRFs, edit checks and custom functions.
  • Responsible for database maintenance.
  • Reviews protocols and addenda in development.
  • In collaboration with senior team members, coordinates interactive review meetings for assigned studies to ensure that forms reviews for assigned studies occur in a timely manner and in accordance with protocol development timelines. Quality control of study setup and validation procedures.
  • Manage multiple priorities, assess needs and adjust workloads and communicate project status accordingly.
  • Performs other duties as assigned.

Job Requirements

Experience/Education:
      • Experience in clinical trials data management and/or electronic data capture (EDC) systems (oncology experience a plus)
      • Proficiency in Clinical Data Management procedures including knowledge of Good Clinical Practice (GCP) preferred
      • Strong computer skills with proficiency in MS Office.  Experience with Medidata Rave or other EDC systems preferred.
      • Knowledge of CDISC, SDTM, CDASH a plus.
      • Excellent written and oral communication skills
      • Bachelor's degree from an accredited college or university or equivalent work and/or life experience.

 
 
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