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Clinical Data Lead

2 months ago

London, Greater London, United Kingdom Parexel Full time

About the Role:

The Senior Clinical Data Analyst will play a key role in the success of our projects at Parexel. As a seasoned professional in clinical data management, you will be responsible for leading and executing clinical data cleaning activities, ensuring the highest quality of data for our clients.

Key Responsibilities:

  • Lead and manage clinical data cleaning activities, including query management and data review.
  • Develop and implement project timelines, including creation, review, and tracking of plans.
  • Review and validate protocols and electronic data capture (EDC) screens.
  • Support data processing activities from database setup to database lock, including SAE reconciliation.
  • Perform user acceptance testing on study database setups.
  • Perform medical coding on small studies.
  • Track and review case report forms (CRFs) and support data entry as needed.
  • Develop and maintain documentation, including CRF completion guidelines.
  • Lead functional quality control (QC) activities and testing.
  • Mentor project team members and serve as a subject matter expert.

Requirements:

  • Bachelor's degree as a minimum.
  • Fluent English language skills.
  • Proven experience in clinical research, preferably in a CRO or pharmaceutical setting.
  • Understanding of global data operations tasks, specifically within data management and database programming.
  • Awareness of relevant regulations, including ICH-GCP and 21 CFR 11.
  • Excellent interpersonal, verbal, and written communication skills.
  • Knowledge of medical terminology and coding dictionaries.
  • Good knowledge of EDC systems and electronic source data capture systems.
  • Good knowledge of database setup activities, including database configuration and data validation.
  • Ability to work in a team environment and possess good analytical skills and attention to detail.
  • Basic knowledge of SAS.

About Parexel:

Parexel is a leading global biopharmaceutical services company, providing a broad range of solutions, from clinical research to commercialization. We are committed to helping our clients succeed in the global marketplace.