Clinical Research Manager

About this role

TFS HealthScience is a leading global mid size Contract Research Organization that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities resourcing and Functional Service solutions.

The Clinical Study Manager is responsible for coordinating and overseeing country and site level study activities while ensuring operational excellence regulatory compliance and high quality study delivery throughout the entire study lifecycle.

As part of our SRS FSP team you will be dedicated to one sponsor a global pharmaceutical company known for scientific leadership strong quality standards and complex multicountry clinical programs.

Key Responsibilities

• Oversee operational delivery of clinical studies at country and site level from feasibility through close out.
• Manage CTIS submissions biobank applications and associated agreements.
• Lead budget and contract negotiations with clinical sites to support study start up and maintenance.
• Write and review ICFs based on an English master template and ensure high quality Swedish versions.
• Use Veeva Vault systems including CTMS and eTMF to maintain oversight and ensure documentation quality.
• Support and guide CRAs including review of monitoring reports and proactive issue resolution.

Qualifications

• Degree in life sciences or a related field.
• Five or more years of clinical research experience including independent CRA experience.
• Strong understanding of ICH GCP including the latest R3 updates.
• Experience with CTIS submissions biobank processes and contract or budget negotiation.
• Hands on experience with Veeva Vault CTMS and eTMF.
• Excellent communication organizational and stakeholder management skills.

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You will be joining a team that values collaboration innovation and making a real difference in the lives of patients.

A Bit More About Us

Our journey began over 27 years ago in Sweden in the city of Lund. As a full service global Contract Research Organization we build solution driven teams working toward a healthier future. Bringing together over eight hundred professionals TFS delivers tailored clinical research services in more than forty countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including dermatology neuroscience oncology and ophthalmology.

Our core values of trust quality passion flexibility and sustainability guide us in every decision we make. They help us attract and retain people who share these values creating a highly engaged and collaborative culture where everyone works together to make a meaningful difference.