04 ago
|
TFS HealthScience
|
Andalucía
04 ago
TFS HealthScience
Andalucía
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 and project leaders and sponsors if required. Train and
support Clinical Data Associates and Clinical Data Managers. Train
and support both internal and external Clinical Study Teams.
Represent TFS Data Management in sponsor and investigator meetings.
Responsible to escalate any issues on projects or the need for
potential SOP deviations. May perform system validation, create
test scripts for system validation as well as perform UAT of ePROs
in collaboration with the CRA. Actively contribute to the
organization and development of processes to enhance the work at
TFS. Qualifications University degree in Life Sciences or Computer
Science. Minimum 8+ years of Clinical Data Management experience,
ideally at Senior or Lead level within pharma or CRO. Proven
experience in study-level data management across multiple clinical
trials and phases (Phase I–III preferred). Strong experience
working in CRO/FSP oversight models, with accountability for vendor
deliverables. Solid exposure to data review, database lock, and
submission-ready data delivery. Strong expertise across the full
data management lifecycle (set-up, conduct, close-out). Good
understanding of CDISC standards. Experience with EDC systems,
preferably Veeva EDC. What We Offer We provide opportunities for
personal and professional growth in a rewarding environment. You
will join a team that values collaboration, quality, and making a
difference in the lives of patients. Our core values of Trust,
Quality, Passion, Flexibility, and Sustainability guide our
decisions and shape our culture. By aligning on these values, we
foster collaboration, innovation, and a shared commitment to
excellence. Together, we make a difference. A Bit More About Us Our
journey began over 30 years ago in Sweden, in the city of Lund. As
a full-service global CRO, we build solution-driven teams working
toward a healthier future. Bringing together over 600
professionals, TFS delivers tailored clinical research services in
more than 50 countries, offering flexible clinical development and
strategic resourcing solutions across key therapeutic areas
including Dermatology, Neuroscience, Oncology, and
Ophthalmology.
📌 Senior Clinical Data Manager (Andalucía)
🏢 TFS HealthScience
📍 Andalucía