Senior Clinical Data Analyst - based in Romania, Poland, Hungary

The 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 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.