Вакансия Senior Clinical Data Manager

Skills

• GCP
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• CDMS

Описание вакансии

We’re looking for bright individuals to join our growing team in the Poland office.
You will be responsible for all aspects of clinical database review, cleaning, reporting, participating in database design and implementation as well as client communication and team oversight. As a Senior Clinical Data Manager, you will establish and maintain policies and procedures for gathering, analyzing, and reporting clinical trial data.

Job responsibilities:

The role of the Clinical Data Manager is to ensure useful, accurate, and reliable information is collected during clinical trials. This involves the careful design of the data collection tools and data interpretation methodology as well as close integration with other clinical study management functions.

General responsibilities include:

• Review clinical trial data in alignment with client SOPs and data review conventions to identify erroneous, missing, incomplete, or implausible data.
• Perform query production, resolution, and tracking to resolve any problematic data identified during the review. Update the database accordingly.
• Create and/or review data management documentation, completion guidelines, DMP, DVS and other specifications.
• Take part in EDC system and CRF components design and testing.
• Interact with clinical, programming, and other project teams, as necessary.
• Communication with the client/sponsor, leading the project.
• Team oversight and tasks planning.

General requirements:

• Bachelor’s Degree, or educational equivalent, in health, clinical, biological, or related discipline, and 3 to 5 or more years of direct data management experience;
• Knowledge of medical terminology, pharmacology, anatomy, and/or physiology;
• Knowledge of operating procedures and work instructions and the ability to apply them in practice;
• Knowledge of GCP and relevant regulatory guidelines;
• Strong English skills. Excellent communication, interpersonal, customer service, and teamwork skills;
• Excellent organizational and analytical skills;
• Comprehensive understanding of the clinical drug development process;
• Experience with electronic Clinical Database Systems is required and experience with electronic reporting applications is preferred;
• Experience with an electronic data capture (EDC);
• Ability to maintain a high degree of confidentiality with clinical data and proprietary data;
• Ability to use interactive computer programs, such as MS Word, Excel, and PowerPoint;
• Extensive data management skills and thorough knowledge of the data management process (e.g., therapeutic area, deep understanding of DM processes, SAE reconciliation/pharmacovigilance, medical review, external data vendor reconciliation, management of central/local laboratory data, and/or new technology).