Principal Clinical Data Manager

Overview

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 Principal Clinical Data Manager- home based in Portugal, Spain, UK or Hybrid in Poland, Sweden.

About this role

As part of our CDS Ophthalmology team you will work alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Principal Clinical Data Manager will work independently on preparing, conducting and completing Clinical Data Management tasks on assigned Study Teams according to company policies, SOPs and regulatory requirements.

Responsibilities

• Responsible for Clinical Data Management activities for assigned studies :
• General mentoring to Clinical Data Managers and Senior Clinical Data Managers on specific Data Management topics as needed
• Act as Lead Clinical Data Manager for assigned data management projects
• Act as a Project Lead for Biometric-only projects
• Coordinate work of other Clinical Data Management staff assigned to the project
• Plan client deliverables and manage project budgets (incl. PFU / revenue files)
• Prepare and distribute periodic project progress reports and oversee preparation of client correspondence
• Coordinate the receipt and processing of information for projects (coding dictionaries, format libraries, and transfer of database specs) as well as electronic data received
• Direct and oversee project-specific initiation and orientation, as necessary, particularly through facilitation of effective kick-off meeting and participation in investigator meetings
• Review Study Protocol
• Develop CRF or review of sponsor-generated CRFs
• Develop Database
• Define and program edit checks
• Responsible to prepare, finalize and archive all related DM documentation
• Develop Data Management Plan and Data Management Report
• Develop Data Validation Plan (including definition of edit checks)
• Develop Data Entry Instructions / eCRF completion guidelines
• Coordinate validation of database, edit checks and trial and site settings
• Performs validation of database, edit checks and trial and site settings in studies where not the responsible CDM
• Perform CRF handling including logging, tracking and sorting
• Train and support Clinical Data Associates and Clinical Data Managers
• 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 senior 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)
• File / archive essential documents
• Provide metrics and status updates to senior management and project leaders and sponsors if required
• Train and support both internal and external Clinical Study Teams
• Represent TFS Data Management in sponsor and investigator meetings
• Coach, support and mentor of (new) employees
• Responsible to escalate any issues on projects or the need for potential SOP deviations
• Perform system validation, create test scripts for system validation as well as perform UAT of ePROs in collaboration with the CRA
• Actively contribute to the organization and development of processes to enhance the work at TFS
• Provide input into proposals which include Data Management and attend Bid Defense meetings face-to-face or via webex
• File / archive essential documents

Qualifications

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

About Us

Our journey began over 29 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.

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