Clinical Data Manager

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.

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.

Key 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.

Qualifications

• Bachelors 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.

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.