Senior Clinical Data Analyst - based in UK, Romania, Poland, Hungary
Romania, Remote Job ID R0000025392 Category Data ManagementAbout this Role
Picture Yourself At Parexel:
The Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate all clinical data validation activities on assigned projects, commensurate with experience and/or project role, with high degree of proficiency and autonomy. Further responsibilities shall include providing technical expertise and/or operational leadership regarding all DM operational activities (data cleaning matrices), processes and Data Management documents regarding data validation. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
SCDA acts as a subject matter expert on DM Systems/processes, providing technical support and expert advice to internal and external sponsors.
The SCDA may act as a back-up to or fulfill the Data Management Lead role where required.
What you will do at Parexel:
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 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.
Ideal candidate will possess:
Bachelor’s degree as a minimum.
Fluent English.
Proven data management experience in clinical research (CRO/Pharma).
Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards.
Sound awareness of relevant regulations, including ICH-GCP, 21CRF11.
Excellent interpersonal, verbal and written communication skills.
Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG).
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.
Good analytical skills and attention to detail.
Basic knowledge of SAS.
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