Clinical Data Lead

Warszawa

Clinical Data Lead
Warszawa
NR REF.: 1173488

For one of our Clients, an international company, we are looking for candidates for Clinical Data Lead role.

The Clinical Data Lead plays a critical role by providing data management expertise and support to the clinical development team, ensuring that data is processed and tracked in compliance with regulatory and quality standards. This position is part of the Clinical Development and is based in Warsaw, Poland.

Responsibilities:

• Responsible for all data management activities on assigned clinical studies, including key deliverables such as Case Report Form development, Data Validation Plan writing and programming, Data Management Plan writing, SAE reconciliation plan and Data Transfer Agreement, in compliance with international regulatory guidelines and internal SOPs
• Develop and validate the clinical database, define and execute user acceptance testing and quality control
• Coordinate, execute or supervise all validation process, data processing and reporting, data reconciliation, query generation and resolution, data cleaning and quality review tasks, from study startup to database lock
• Act as the primary point of contact for Data Management with the study teams, CRO and external vendors, and coordinate the data management activities for outsourced clinical studies
• Provide input for Clinical Investigation Plan and liaise with the study teams on other key study deliverables and documents.

Qualifications and Job Specifications:

• Minimum B.Sc. degree in a scientific or relevant discipline
• Minimum of 5 years of operational experience in clinical data management
• Operational experience with a major EDC platforms (e.g. IBM, RAVE)
• Proficiency in Microsoft Excel
• Knowledge in biostatistics and SAS programming a plus
• Excellent organizational and analytical/problem-solving skills
• Ability to work independently, in a matrix environment and with virtual teams
• Knowledge of ICH-GCP guidelines and medical terminology
• Fluent in English

Sounds interesting? Apply and talk with us about more details!

Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361. #1172590