Senior Clinical Data Analyst - based in Romania, Poland, Hungary
Răspunde la anunțThe role can be flexibly based in Romania, Poland or Hungary
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
- 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.
- 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. Med
DRA & WHODRUG). - Good knowledge of EDC systems ( e. g. , Data
Labs, Rave. ) - Good knowledge of electronic source data capture systems (e. g. Clin
Base). - Good knowledge of all DB
- 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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