About this role 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.
The Senior Clinical Data Manager is part of the Integral 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. Key Responsibilities 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. 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

📌 Senior Clinical Data Manager (Andalucía)
🏢 TFS HealthScience
📍 Andalucía