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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Clinical Data Analyst (Bloemfontein or Pretoria)Job ID 64855BR Bloemfontein, Orange Free State, South Africa
* The Senior Clinical Data Analyst (SCDA) shall independently perform all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role.
* Further responsibilities shall include acting as Study Team Lead, support on data processing activities and study level documents e.g. Protocol Deviation Specification, Data Validation specification, etc.
* The SCDA may act as a Data Management Lead where required.
* Assume the ability to meet the requirements of a CDA III roIe with a high degree of proficiency and autonomy
* Lead/Responsible for data cleaning and data review activities e.g. query management.
* Management of project timelines (including creation, review and tracking of plans)
* Review of protocols and EDC Screens if required.
* Support data processing activities from database setup to database lock, e.g. SAE reconciliation.
* Perform user acceptance testing on study database setups.
* Perform medical coding on small studies
* Track and review CRF's. Support data entry where required.
* Perform and or support the setup of DM documents and ensure proper documentation e.g. CRF Completion Guidelines (CCG)
* Perform/lead functional QC activities and testing
* Mentor project team members
* Be a subject matter expert when needed
QualificationsKnowledge and Experience:
* Experience in clinical research
* Good interpersonal, verbal and written communication skills
* Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG)
* Ability to work in team environment
* Good analytical skills and attention to detail
* Effective time management to meet daily metrics or team objectives, completion of assigned tasks in a timely manner
* Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and Parexel SOP's and study specific procedures
* Good knowledge of EDC systems (e.g. DataLabs, Rave.)
* Good knowledge of electronic source data capture systems (e.g. ClinBase)
* Good knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation
* Basic knowledge of SAS
* Bachelor’s degree and / or other medical qualifications or relevant industry experience
* Personal skills that include:
o Good interpersonal, oral and written communication skills
o Excellent learning ability
o Work with integrity
* Business / Operational skills that include:
o Commitment to quality
o Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards
o Sound awareness of relevant regulations, including ICH-GCP, 21CRF11
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