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Lead RAVE Study Builder

Employer
Labcorp
Location
Office based Leeds, Yorkshire or home based UK
Salary
Competitive + full and comprehensive benefits package
Start date
24 May 2019
Closing date
23 Jun 2019

Job Details

  • Lead RAVE Study Builder required to work for Covance
  • Varied, fast paced environment
  • Office based in Leeds, Yorkshire, UK or work from home anywhere in Europe
  • Candidates must have experience of working with RAVE providing technical services for building clinical trial databases

Join our growing team and discover your extraordinary potential by working as a Covance Lead RAVE Study Builder within our Early Phase (Phases I & II) data management department.  The Lead RACE Study Builder will provide technical services for building clinical trial databases within EDC environments (mainly RAVE) for assigned clinical trial projects to achieve project integrity, on time delivery and quality data. 

Working within our early phase group we offer, in a word, variety

In the type of studies: PK, Bioequivalence, Metabolism, Dose Escalation etc. and Sponsors

  • In Early Phase we are not assigned for years to the same study, so you will be exposed to multiple studies for clients with different needs as well as working with talented internal colleagues

Job Primary Functions

  • Perform study build and design activities including preparing eCRF specification, annotated data capture instruments and screen development according to internal Covance procedures.
  • Participate and conduct, as necessary, sponsor screen design review meetings.
  • Creation and review Edit Check Specifications.
  • Program, test, validate, and maintain derivation and edit check procedures in the EDC and related environments based on the Edit Check Specification, eCRF specification or data capture instrument and the protocol.
  • May program custom functions and custom reports in EDC systems
  • Conduct quality control of study build and design activities including eCRF specification or annotated data capture instruments, screen design, validation checks and edit check specification for assigned projects.
  • Provide technical support as needed for additional study build tool functionality including, but not limited to, reporting, outputs, Data Transfer Agreements (DTAs) and lab administration.
  • Support test script development and performance of user acceptance testing including the testing of screens, edit check functionality, and work flow checks as necessary.
  • Participate in all post live study changes including risk assessment, specifications, testing, and interactions with study team for shared activities.
  • Serves as lead on project teams to coordinate and lead study build and design activities.
  • Participates in meetings and discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism.
  • Regularly inform those responsible for study project management of any issues that might impact project deliverables, target dates, scope, or budget and escalates potential problems effectively and in a timely proactive manner.
  • With some supervision support third party vendor tools, like IxRS and ePRO, integration as assigned.
  • Support Clinical Data Managers and other study team members to address any issues that arise time to time throughout the study conduct.
  • Support the validation of EDC and other supporting software as needed.
  • With some supervision and training generate reports using business intelligence tools.
  • Manages multiple task assignments, project resources, proactively alerting management of delivery and resourcing needs.
  • Monitors the scope of work to actual work, alerting management of potential change orders. Manages and executes the change order to completion. Provides input and supporting details for change orders.
  • Supports study build, design and other clinical programming activities independently and concurrently on multiple studies depending upon study complexity, Covance or client specific study build standards, scope, third party vendor integrations, and resourcing requirements.
  • Provide clinical sites with training on screen design and data entry conventions.
  • Assists in mentoring and training other Clinical Operations and Data Management staff, and will participate on SOP, best practices, and process improvement teams as assigned
  • Interact with IT and related technical support staff on study build and design issues.
  • Provides timely support to the study team on all programming matters according to the project plan and programming specification using internal, standards and guidelines.
  • Assist with the creation of listings and reports using clinical reporting and business intelligence tools and contributes to the reporting of clinical data.
  • Ensures secure and high integrity data transfers from vendors using data transfer standards.

Job Qualifications

  • Bachelor’s Degree in Computer Science or Life Sciences or equivalent education and relevant experience.
  • Fluent in English, both written and verbal
  • Knowledge of GCP and ICH guidelines
  • Proficiency in CDASH/CDISC data standards
  • Previous clinical research experience in database design/programming and change control.
  • Experience with clinical trial process and data management, CRF Design, edit check programming, and data exports
  • Proficient in the relationship and regulatory obligation of the CRO industry with pharmaceutical/ biotechnological companies
  • Demonstrate ability to work in a team environment and collaborate with peers
  • Demonstrate good organizational ability, communication and interpersonal skills
  • Demonstrate problem solving skills and a proactive approach
  • Time management skill and ability to adhere to project productivity metrics and timelines
  • Flexibility and agility to adapt to changing scope of work
  • Knowledge of Simple Query Language (SQL)
  • Knowledge of JavaScript or other programming/scripting languages

PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSE

NO AGENCIES PLEASE

MORE INFORMATION AVAILABLE ON REQUEST

About Covance:

As the drug development business of LabCorp and the world’s most comprehensive drug development service company, we have helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today.  Because of our broad experience and specialized expertise, we’re in a unique position to supply insights that go above and beyond testing.  Together with our clients, we create solutions that transform potential into reality.  For more information on Covance please visit: www.covance.com

Keywords:

Clinical data management, data management, EDC Programmer, Study Builder, Database Programmer, Study Developer, Rave Study Builder, Senior Clinical Programmer, Covance, Early Phase, Phase 1, Phase I, Phase One, Phase II, Phases 2, Phase Two, SAS Programmer, Lead, RAVE, CDISC, CDASH, pharma, pharmaceutical, CRO, Contract Research Organisation, Contract Research Organization, home based, field based, office based, office-based, home-based, flexible working, flexible location,home based EU Anywhere, anywhere in Europe, field-based, United Kingdom, UK, Great Britain, England, Scotland, Wales, Northern Ireland, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, Russia, Slovakia, Spain, Ukraine, Leeds, West Yorkshire, Bradford, Huddersfield, Manchester.

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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