CLINICAL PROGRAMMER- RAVE OR ORACLE INFORM

Leeds  ‐ Onsite
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Keywords

Description

I am currently looking for a Clinical Data Programmer / Lead Designer with experience in working with RAVE and Inform ideally to be based in Leeds but we could also considering candidates being home based.

In this role you will be working as part of a global team and have an excellent opportunity to develop within your role.

About the Job
  • Technical leadership with responsibility for delivering technical services (Electronic Data Capture (EDC), Paper Data Entry (PDE), Bedside Data Capture, Imaging and Thesaurus Management System) and management of integration of data streams of vendor data within the scope of assigned projects.
  • Oversee CRF Design (Paper CRFs/ annotations and/or for EDC applications) within the scope of assigned projects.
  • Act as technical liaison with project team members, client and Data Managers to drive the technical aspects of project delivery.
  • Client facing, project and study budget management. Expected to Lead EDC Builds and mentor the study team in setting up Medidata RAVE, Oracle Inform, Oracle Clinical, Oracle Remote Data Capture and/or Bedside Data Capture databases.
  • Delegates and oversees the project work of technical and design staff.
  • Assess resource requirements for allocated projects on a regular basis.
  • Manage projects within the scope of assigned budgets.
  • Notify project leadership of requests for out-of-scope work and advise management of changes in scope of projects to enable the timely development of change orders.
  • Mentorand aide in staff development, and achievement of competency standards
  • Assist in the development and implementation of solutions to global technical service issues and concerns regarding Medidata RAVE, Oracle Inform, Oracle Clinical, CRF Design, Bedside Data Capture and/or imaging activities, including proactive prevention strategies
  • Assist in development of global technical services competency models
  • Assist with the development of training programs to ensure staff, project and technical, achievement of position competencies. Present training programs to the technical staff regarding study build, change control and/or CRF Design.
  • Participate in the development of global, harmonized SOPs and specific quality work instruction for technical service group activities
  • Maintain technical competency through participation in internal and external professional seminars and participation in professional organizations such as Oracle's Health Sciences Innovation Forum or Medidata's User Group (MUG).
  • Provide support and trouble-shooting of EDC, PDE, Imaging and act as the study team liaison.
  • Provide support to data management for time and cost estimates and prepare and present to potential clients on global technical support capabilities.
  • Complete work according to SOPs, Work Instructions ,and project specific guidelines in accordance with Good Clinical Practice
  • Meet with data manager on assigned projects to discuss technical strategies, contractual obligations and timelines. Escalate resource needs as appropriate.
  • Provide leadership and consultation in the area of database design and development with data managers.


About You
  • University/college degree, ideally in life science, computer science, programming, pharmacy or related subject
  • Broad knowledge of drug development process and knowledge of the Oracle Clinical Data Management System
  • Working knowledge of SAS, SQL, SQL-Plus, PL/SQL and relational databases
  • Knowledge of budgets and relationship to productivity targets
  • Thorough knowledge of Medidata RAVE, Oracle Inform, Bedside Data Capture and/or
    Oracle Remote Data Capture to ensure the efficient integration and adaptation of
    remote data capture tools
  • Working Knowledge of System Validation Life Cycle in relationship to the implementation new applications
  • Completed the Inform Central Designer course in Inform 4.6, 5.0 or 5.5 would be highly beneficial
  • Ability to work in a global team.
  • Fluent in English, both written and verbal
  • Interpersonal and effective communication skills
  • Ability to work independently as well as part of a team
  • Recognition of the importance of timelines within projects


This is your chance to become part of a team that helps to bring miracle of medicine to market sooner. This role offers unsurpassed growth and career development opportunities.

Education/Qualifications
  • University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology)
  • Broad knowledge of drug development process
  • Knowledge of budgets and relationship to productivity targets
  • Thorough knowledge of Medidata RAVE, Oracle Inform, Bedside Data Capture and/or Oracle Remote Data Capture to ensure the efficient integration and adaptation of remote data capture tools
  • Working knowledge of CRF Design.
  • Knowledge of time and cost estimate development and pricing strategies
  • Working Knowledge of System Life Cycle in relationship to the implementation new applications
  • Fluent in English, both written and verbal


Experience
  • Minimum ten years of relevant work experience to include data management and/or database programming activities including 5 years Medidata RAVE, Oracle Inform, Oracle Remote Data Capture, Bedside Data Capture or equivalent experience
  • Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions.
  • Demonstrated skill in leading teams, by example and mentoring staff
  • Demonstrate excellent problem solving skills, a proactive approach and a willingness to make decisions on a regular basis and communicate these clearly.
  • Excellent oral and written communication and presentation skills
  • Knowledge of clinical trial process and data management, CRF Design, SAS programming and systems applications to support operations
  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies
  • Demonstrated ability to work in a team environment
  • Demonstrated ability to handle multiple competing priorities
  • Proven managerial and interpersonal skills.


If you are interested in this role, have any questions about this position or would like to register your interest in other positions, please feel free to send your up to date CV to or contact Oliver Davies on

To find out more about Real please visit www.realstaffing.com
Start date
08/2013
Duration
6 Month
From
Real Staffing
Published at
30.07.2013
Project ID:
573684
Contract type
Freelance
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