Clinical Research Manager at TFS HealthScience

Stockholm, , Sweden -

Full Time

Start Date

Immediate

Expiry Date

17 Feb, 26

Salary

0.0

Posted On

19 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Regulatory Compliance, Budget Negotiation, Contract Negotiation, CTIS Submissions, Biobank Processes, Veeva Vault, CTMS, eTMF, Communication Skills, Organizational Skills, Stakeholder Management, GCP, Monitoring Reports, Issue Resolution

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

The Clinical Study Manager is responsible for coordinating and overseeing country and site level study activities while ensuring operational excellence and high quality study delivery. This includes managing clinical studies from feasibility through close out and supporting CRAs in their roles.