Clinical Data Manager

Apsida Life Science have partnered with a leading global pharmaceutical company to present the following role:

Role:
Trial Data Manager

Duration :
12 months

Location:
Switzerland

Competitive Salary Rate

Company Overview:

The client company is a biopharmaceutical company that focuses on developing and commercializing medicines, particularly in the cardiovascular field and immunological disorders.

Job Responsibilities

• Meets study timelines in terms of Data Management deliverables
• Ensures data handling consistency within allocated study(ies)
• Leads Data Management activities for assigned study
• Provides Data Management input to the development of the study protocol
• Organizes, monitors, and tracks the testing of data entry screens (eCRF layout), data cleaning / review tools, and their implementation in the production environment
• Organizes, monitors, and tracks data cleaning, data review, query management, and database lock; makes sure processes are driven in collaboration with key Clinical Development (CD) stakeholders Generates study metrics and status reports
• Represents Data Management at Clinical Trial Team (CTT) meetings
• Manages and is accountable for Data Management activities in studies where Data Management is outsourced (insourcing/outsourcing partners' management)
• Prepares and archives Data Management study documentation
• Presents study related topics at CTT, Investigators and Monitors meetings
• Participates in development and review of policies, Standard Operating Procedures
• (SOPs), and associated documents for Data Management
• Represents Data Management in cross functional working groups related to the system / process
• Ensures Data Managers assigned to study have required training
• Ensures Study Data Tabulation Model (SDTM) deliverables (Including SDTM datasets, and annotated CRF) are created, validated, and provided as per agreed timelines
• Performs and/or coordinates Quality Control (QC): Periodic operational checks to verify that clinical data are handled according to protocol, applicable Quality System (QS) documents and GCP

Required Qualifications and Experience

• Recognized degree in life sciences, mathematics, statistics, informatics, or related disciplines
• At least 3 years' experience in Pharmaceutical or Biotech industry within Clinical Research and / or Clinical
• Data Management with good level of functional expertise in Data Management
• Good knowledge of international clinical research regulations and requirements (e.g., International
• Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report
• Form (CRF) design

If you are interested in learning more, please reach out to Mufaro Mpofu:

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process

Compétences idéales

• Data Management
• Quality Control

• Basel, Basel-Stadt, Switzerland

Expérience professionnelle

• Data Analyst

Compétences linguistiques

• English