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 Research Manager is responsible for overseeing clinical operations deliverables across countries and sites ensuring high-quality study execution in compliance with ICH GCP SOPs and protocol requirements. You will act as a key operational lead within the project team supporting monitoring strategy site management oversight and study delivery.
As part of our SRS FSP team you will be dedicated to one sponsor and play a central role in the execution of a Phase 2 clinical study within cardiology.
Key Responsibilities
Oversee all monitoring and site management activities to ensure compliance with ICH GCP SOPs and study protocols
Lead support and provide oversight to CRAs including training performance follow-up and quality review of site activities
Develop and implement monitoring plans site training plans and recruitment strategies
Review and approve monitoring visit reports and ensure timely follow-up of action items
Act as primary point of contact for the monitoring team and support site issue resolution and escalation
Ensure accurate and timely updates in CTMS and maintain oversight of study progress at site and country level
Qualifications
Degree in life sciences or related field
Minimum 7 years of clinical research experience including on-site monitoring
Previous experience as Clinical Research Manager or equivalent role
Experience with line management or functional oversight of CRAs
Strong knowledge of ICH GCP and clinical trial processes
Experience in Phase 2 studies is preferred
Willingness to travel approximately 20 to 30 percent
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.
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, ... View more