Clinical Data Manager- Contract/ Permanent

Clinical Data Manager- Contract/Permanent

Job Description

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.

Location: UK/EU Remote

Employment Type: Contract/Permanent

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 finalisation 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 organisation 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.

Skills, Experience & Qualifications

· Bachelor's Degree, preferably in life science, informatics, statistics, nursing or equivalent education or equivalent demonstrable experience

· Minimum 2 years relevant experience in clinical research, drug development, data management, or other healthcare environment

· Proven data management skills

· Good written and communication skills

· Ability to deal effectively with sponsors and internal customers

· Ability and willingness to travel on occasion

Note: Candidates must have the right to work in the UK/EU as clients are unable to offer sponsorship.