Senior Clinical Data Manager

Overview

TFS HealthScience is excited to be expanding our Data Management team and we are looking for an experienced, highly motivated Senior Clinical Data Manager who shares our vision of providing clinical research excellence. Our Data Management team is a highly experienced international group of professionals led by an industry expert.

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.

Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation.

Together we make a difference.

TFS HealthScience is looking for a Senior Clinical Data Manager - home based in either UK, Germany, Poland, Italy or Israel.

We look forward to receiving your application soon!

What can we offer you?

A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.

Responsibilities

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

• Responsible for Clinical Data Management activities for assigned studies:
• 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
• 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
• Support the CRAs in study related questions
  
  

• Bachelor’s Degree, preferably in life science or nursing, Statistics or Computer Science or equivalent education or equivalent lower education e.g. Associate Degree
• Minimum 5 years relevant data management experience
• Proven data management skills
• Excellent English verbal and communication skills
• Ability to deal effectively with sponsors and internal customers
• Ability and willingness to travel on occasion