Senior Clinical Data Analyst

Highly Competitive
  1. Permanent
  2. Data Management
  3. United Kingdom
London, England
Posting date: 17 Dec 2020

An opportunity has arisen in London for a Senior Clinical Data Analyst to join a global biotech and make massive contributions to science.The Senior Clinical Data Analyst shall independently perform all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role. Further responsibilities shall include support on data processing activities and study level documents e.g. Protocol Deviation Specification, Data Validation specification, etc. The Senior CDA may act as a Data Management Lead where required.

Job Responsibilities

  • Lead/Responsible for data cleaning and data review activities e.g. query management.
  • 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 CRFs. 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.

Skills and Requirements

  • Bachelor's degree as a minimum
  • Proven ability to lead and collaborate with global and cross-functional teams - ability to coordinate & prioritize tasks for the DM operational and programming teams (when) in the Primary CDA role.
  • Ability to independently interact with Sponsor liaison to discuss data issues/project data validation requirements, as needed.
  • Experience and understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards.
  • Experience in clinical research (Pharma/CRO).
  • Excellent interpersonal, verbal and written communication skills.
  • Knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG).
  • Robust knowledge of ICH-GCP Guidelines.
  • 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.
  • Ability to work in team environment.
  • Fluent English.
  • Effective time management to meet daily metrics or team objectives, completion of assigned tasks in a timely manner.
  • Basic knowledge of SAS.

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.