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Sr Clinical Data Prgrming Lead

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About the role

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Senior Clinical Data Programming Lead
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.  The Clinical Data Programming Lead role is either part of the Clinical Data Management Systems (CDMS) group involved in clinical database build and maintenance or the Clinical Data Services (CDS) group involved in clinical data receipt , programming and delivery. The Clinical Data Programming Lead is responsible for overseeing Clinical Data Management System set up and maintenance as well as providing advanced technical support related to Clinical Data Management Systems required for clinical studies.
 
 
 
Overview of the Role
  • The Clinical Data Programming Lead participates in activities as related to building study databases and applies competent knowledge of the programming of moderate CRF design, database building, edit checks, reports, custom programming, system interfaces and all system feature configurations.
  • Serves as the lead on study specific database design within the CDMS system (i.e. Oracle RDC, Oracle Inform, Medidata  Rave, DataTrak UX EDC, Oracle Clinical and CRF WorkManager) , leading clinical database programming activities on multiple studies of simple to moderately complex design and expert in all areas for relevant CDMS.                         ·
  • *Reviews database specification documents created by study teams , such as CRF Specifications and Data Validation Specifications (DVS).
  • *Builds clinical study database CRF screens per CRF Specifications provided by project team .
  • *Creates/Programs edit checks , special actions/functions , custom programs and derivations as per a DVS.
  • *Plans and schedules edit check test script writing, edit check programming and edit check validation with the centralized CDMS Testing group and centralized CDMS Programming group. Manages timelines for edit check process, ensures issues are addressed in a timely manner to meet timelines and produces edit check validation packages for delivery to the study teams to file in the Trial Master File.
  • *Completes study database updates as specified per Change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes
  • *Configures study specific data interfaces such as IVRS, labs, and CTMS.
  • *Serves on project teams to coordinate and lead CDMS activities for clinical database programming projects. Attends meetings, participates in discussions , uses an analyt ical  approach  to  problem solving, focuses on deliverables , and provides constructive criticism . Keeps those responsible  for project management informed of any issues that might impact project target dates, scope or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources .
  • *Trouble-shoots and solves study building issues and/or system integration issues (such as  IVRS failures, CTMS issues), and/or change request issues using the appropriate applications.
  • Creates advanced CDMS custom programs as per DVS, as required .
  • Ensures high quality deliverables by providing review of study-level/program -level I multi- study core deliveries for accuracy .
  • Attends sponsor audits and assists with in-progress audits, including presenting the CDMS  process and procedures and presenting the validation documentation  produced by the CDMS group .
  • To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features . Participate in Data Management department initiatives .
  • Plan for the study execution in detail thereby providing clarity on all aspects of the setup progress (Round 1 programming date, testing dates , UAT dates)
 
 
Role Requirements
  • To perform this job successfully , an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge , skill, and/or ability required . Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions .
  • US/LATAM/CAN :  minimum 2 years of experience in building study databases (CDMS) or minimum 4 years of experience clinical data programming and delivery (CDS).
  • EU/APAC:   prior experience  in building study  databases  (CDMS) or clinical data  programming  and delivery (CDS) .
  • Experience in Oracle RDC, Phase Forward Inform, Medidata Rave, DataTrak UX EDC, Oracle Clinical or CRF WorkManager  required (CDMS only)
  • Demonstrated ability to produce CDISC and Sponsor defined clinical data deliverables (CDS only) .
  • Experience with clinical data programming  and the ability to  review and evaluate clinical data (CDS only) .
  • Extensive problem solving skills for tasks/functions related to his/her group .
  • Strong organizational,  prioritization  and time  management  skills as to effectively  organize workload and complete assignments .
  • Ability to successfully manage multiple tasks and timelines.
  • Ability to perform assigned tasks with little supervision.
  • Ability to liaise professionally with team members .
  • Team player with strong verbal and written communication skills.
  • Demonstrated ability to learn new technologies , applications and techniques .
  • Knowledge of database concepts .
  • Due to the nature of this position' it may be required for the employee to travel. Therefore , dependent on the employee 's location, the employee may be required to possess a valid Driver's license.
  • Bachelor's degree in information systems , science or related discipline or relevant experience required .
 
Benefits of Working in ICON
 
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   
 
What’s Next?
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
 
 
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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