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Clinical Data Analyst
Ref No.: 18-01126
Location: Warsaw, Indiana
Start Date: 02/02/2018
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;

Leadership Competencies:
  • Connect – Support strategic partnerships with Clinical System and IT leaders at the Enterprise level to ensure MD sector needs are communicated and understood, and with franchise and clinical operations leaders to ensure effective implementation and utilization of systems within the Clinical R&D CoE
  • Shape – Develop knowledge of therapeutic areas within the Franchises and adapt ADaM and STDM standards for medical devices for use in the MD sector; participate in industry initiatives to define/refine STDM standards
  • Lead – Mentor team mates to ensure consistency in process execution and quality system execution
  • Deliver – ensure upgrades and maintenance of clinical systems are delivered on time, within budget and in compliance to regulations and SOPs, seamlessly across all Franchises

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.