Principal Clinical Data Manager Lisboa

Overview

TFS Health
Science is a leading global
- size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full
- 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 be working 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.

Key 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
  - specific initiation and orientation, particularly through facilitation of effective
  - off meetings and participation in investigator meetings
• Review Study Protocol, develop CRF or review
  - generated CRFs
• Develop Database
• Define and program edit checks
• 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/e
  CRF completion guidelines
• Coordinate validation of database, edit checks and trial and site settings
• Validate database, edit checks and trial and site settings in studies where not the responsible CDM
• CRF handling including logging, tracking and sorting
• Train and support Clinical Data Associates and Clinical Data Managers
• Support the CRAs in
  - related questions
• Perform Data cleaning and query handling
• Ensure completion of Quality Control tasks 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)
• 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 (new) employees
• Escalate any issues on projects or the need for potential SOP deviations
• Perform system validation, create test scripts for system validation and perform UAT of e
  PROs in collaboration with the CRA
• Contribute to the development of processes to enhance the work at TFS
• Provide input into proposals which include Data Management and attend Bid Defense meetings (in person or via Webex)

Qualifications

• Bachelor’s Degree, preferably in life science or nursing, Statistics or Computer Science or equivalent education
• Minimum of 8 years of relevant data management experience, including 5 years as Senior Clinical Data Manager
• Familiarity with medical terminology
• Ability to handle multiple tasks to meet deadlines
• Proven leadership skills
• Excellent English verbal and written communication skills
• Ability to deal effectively with sponsors and internal customers
• Ability and willingness to travel on occasion

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 Lund, Sweden. As a
- service, global Contract Research Organization (CRO), we build
- driven teams working towards a healthier future. We employ over 800 professionals 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 are Trust, Quality, Passion, Flexibility, and Sustainability.

Together we make a difference.