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Data Manager

hace 3 meses

Barcelona, Barcelona, España TFS HealthScience A tiempo completo

Overview:


TFS HealthScience is excited to be expanding our SRS
team and we are looking for an experienced, highly motivated Clinical Data Manager who shares our vision of providing clinical research excellence.

Our SRS 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, Passion and Sustainability 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 Clinical Data Manager in Barcelona or Madrid, Spain.

This role will sit embedded within one of our prestigious clients who promotes rapid career development.

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.


Benefits include:

Health Insurance

Lunch allowance

Home allowance

Possibility to compensate overtime

Flexibility

Summer working hours

Responsibilities:

Purpose
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.

Responsibilities
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

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

  • TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the _privacy notice_ for further details._
  • TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits._