Clinical Data Analyst II - based in Romania, Poland, Hungary
Răspunde la anunțThe role can be flexibly based in Romania, Poland, Hungary.
Picture yourself at Parexel:
The Clinical Data Analyst II (CDA II) performs all clinical data validation activities on assigned projects, commensurate with experience and/or project role with minimal guidance and supervision from Line Manager and/or Subject Matter Expert. Further responsibilities shall include support on data validation activities, Data Management documents and data cleaning matrices e. g. Data Validation Specification, CRF Completion Guidelines, Protocol Deviation Specification, Mock Shells for Off-line listing etc.
All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
CDA II may act as a mentor for ACDA or other CDA peers and also as a process lead on a specific data validation activity.
What you will do at Parexel:
Data Validation (cleaning):
- Lead/Responsible for data validation (cleaning/review/reconciliation) activities during conduct and database lock (Primary CDA), e. g. query management, manual/SAS listing reviews and external vendor data reconciliation
- Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines
- Lead/perform user acceptance testing on clinical database setups.
- Review protocols and EDC Entry Screens if required
- Provide input on the data management timelines and coordinate the DM operational activities during database set up
- Track and review CRFs. Support data entry where required
- Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
- Perform/Lead functional QC activities on databases and/or patient data, as per business needs
- Maintain training compliance as per Job Roles assigned, including On-the-Job training
- Address training needs, as per Development Goal/s identified
- Provide relevant
-
- job training to staff and project teams as appropriate - Act as Mentor for other clinical data analysts
- Proven data management experience in clinical research industry (CRO/Pharma)
- Bachelor’s degree and / or other medical qualifications or relevant industry experience
- Good understanding of data management processes and data validation flow (e. g. Data cleaning, DB lock)
- Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures
- Good knowledge of Clinical Data Management Systems (e. g. In
Form, Rave, Veeva, Data
Labs, Clin
Base) - Good understanding of Clinical Study Team roles within Data Management
- Written and oral fluency in English
- Good knowledge of medical terminology and coding dictionaries (e. g. Med
DRA & WHODRUG) - Good knowledge of Data Management Operational processes and tasks during study
- up, conduct and
- out - Good knowledge of Database
- up activities, including but not limited to Database Configuration Specifications and setup of Data Validation - Basic knowledge of SAS (programmed listings)
- Basic knowledge of Data standards (CDISC)
- Strong technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills)
- Good interpersonal, oral and written communication skills
Fii primul, care se va înregistra la oferta de muncă respectivă!
-
De ce să cauți de muncă pe Lucrezi.ro?
În fiecare zi oferte noi de muncă Puteți alege dintr-o gamă largă de locuri de muncă: Scopul nostru este de a oferi o gamă cât mai largă de opțiuni Lasă să-ți fie trimise noile oferte prin e-mail Fii primul care răspunde la noile oferte de muncă Toate ofertele de muncă într-un singur loc (de la angajatori, agenții și alte portaluri) Toate serviciile pentru persoanele aflate în căutarea unui loc de muncă sunt gratuite Vă vom ajuta să găsiți un nou loc de muncă