Senior Clinical Data Manager

TFS HealthScience is a global, mid-sized contract research organization (CRO) partnering with biotechnology and pharmaceutical companies across the full clinical development lifecycle. Our expertise spans full-service clinical development, project-based support, strategic resourcing, and Functional Service Provider (FSP) solutions, matching experienced professionals to roles where they deliver the greatest impact.

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 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.

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.