Job Details

  • Title: Medidata Rave Programmer
  • Code: RCI-3077011
  • Location:
  • Posted Date: 09/16/2020
  • Duration: 4-6 Months
Talk to our Recruiter

  Job Description

OVERALL RESPONSIBILITIES:

Responsibilities include coordination of timelines and resources required to implement and maintain a variety of clinical systems as well as provide oversight and coordination of all aspects of the development and management of clinical study databases across a variety of platforms.  Coordination of activities will require the development of strong, productive relationships with colleagues across the MD sector.   This individual performs with little to no supervision.

 

POSITION DUTIES & RESPONSIBILITIES:                                             

  • Collaborate with Data Management leadership (including Programming and Biostatistics) to define and document data and process standards;
  • Provide in-house project support for creation, routing and approval of all system deliverables associated with clinical systems;
  • Support the development and maintenance of global harmonized processes and procedures for system support;
  • Support vendor evaluation, selection, contracting, and oversight activities for outsourced systems; Assist with vendor evaluation and selection activities for clinical systems;
  • Work with BSDM partners, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines and milestones for study-specific systems set-up, UAT, maintenance and closeout as required;
  • Lead project management activity related to the deployment of Interactive Voice/Web Response Systems (IxRS), Electronic Data Capture (EDC) Systems, CTMS, eTMF and other relevant platforms (as assigned);
  • Create, review and facilitate approval of system deliverables and facilitate appropriate quality review where applicable;
  • Mentor peers through review of deliverables to minimize delays during the quality review process;
  • Interface between Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools;
  • Facilitate  support requests associated with clinical systems (as needed);
  • Serve as first line of contact from study initiation through go live for each clinical study. Systems may include: CTMS, eTMF, IxRS, EDCs;
  • Facilitate the development of training materials and programs related to system set-up, UAT and ongoing maintenance as well as other relevant processes;
  • Represent the Medical Devices Sector on Enterprise or cross-sector Clinical System teams (as needed);
  • Assist with the implementation of study metrics;
  • Analyzes complex change requests to determine feasibility for incorporation within clinical studies;
  • Evaluates vendor supplied release documentation for implementation feasibility and collaborate with appropriate partners to define project parameters;

 

Functional and Technical Competencies:

  • Experience with at least one clinical system (EDC, CTMS, eTMF and IxRS) is required;
  • Previous experience in Clinical Operations preferred;
  • Demonstrated ability to manage a project in a team environment to deliver critical milestones;
  • Strong proficiency in more than one Clinical system. Advanced certification preferred;
  • Experience with CDISC STDM preferred;
  • Excellent verbal and written communication skills;
  • Knowledge of GCP and SDLC;

 

EDUCATION & EXPERIENCE REQUIREMENTS:

A Bachelor’s degree (or equivalent) in Statistics , Computer Science or related discipline (required), with at least 6 years of system support in clinical research within Medical Device or Pharmaceuticals.