Clinical Data Manager

CLINICAL DATA MANAGER - TEMPORARY CONTRACT (1 year with possibility to extend)

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a Clinical Data Manager

About This Role

Clinical Data Manager is part of the Global Biometrics Department within Clinical Development and will work operationally on preparing, conducting and completing Clinical Data Management tasks on assigned Study Teams, according to company policies, SOPs and regulatory requirements.

Key Responsibilities

Responsible for Clinical Data Management activities for assigned studies

• May act as a Lead Clinical Data Manager
• Coordinate work of other Clinical Data Management staff assigned to the project
• Provide guidance for Data Entry and Data Associates
• Review Study Protocol
• Develop CRF or review of sponsor-generated CRFs
• Develop Database
• Responsible to prepare, finalize and archive all related DM documentation
• Define and program edit checks
• Develop CRF completion guidelines
• Coordinate validation of database, edit checks and trial and site settings
• May perform validation of database, edit checks and trial and site settings in studies where not the responsible CDM
• Support the CRAs in study related questions
• Perform Data cleaning and query handling
• Ensure completion of Quality Control task for the finalization and transfer of the study database and related documents to the sponsor
• May coordinate SDTM mapping with the programmer when needed
• Carry out all tasks related to database closure Provide CDs with study documentation to the sites (patient data, audit trail and closed queries)
• Train and support both internal and external Clinical Study Teams
• Represent TFS Data Management in sponsor and investigator meetings
• May provide input into proposals which include Data Management
• Actively contribute to the organization and development of processes to enhance the work at TFS
• File/archive essential documents
• Perform CRF handling including logging, tracking and sorting
• May perform system validation, create test scripts for system validation as well as perform UAT of ePROs in collaboration with the CRA

Requirements

• Bachelor’s Degree, preferably in life science, informatics, statistics, nursing or equivalent education or equivalent demonstrable experience
• Minimum 2 years relevant experience in clinical data management
• Knowledge of CDISC standards
• Programming in Python, R or SAS
• Management of tools such as Power BI
• Proven data management skills
• Good written and communication skills

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.