Senior Clinical Trial Manager

TFS HealthScience is excited to be expanding our Strategic Resourcing team and we are looking for an experienced highly motivated Senior Clinical Trial Manager to be sponsored based in Copenhagen Denmark.

Responsibilities

As the Sr. Clinical Trial Manager you will have a handon role in the planning implementation and execution of all clinical trial activities from study startup through execution and closeout. Your role will involve:

• Lead the clinical trial team and provide expertise in clinical operations within crossfunctional teams.
• Develop and oversee project plans to ensure adherence to timelines quality and budget.
• Manage vendor selection and oversight including RFP processes vendor meetings and monitoring report reviews.
• Develop Sponsor plans for oversight and risk management and maintain Sponsor trial documentation.
• Manage trial budgets within constraints.
• Support the development of studyrelated documentation including protocols ICFs Investigational Brochures and Clinical Study Reports.
• Identify and generate pertinent clinical operation SOPs and assist in reviewing and developing company SOPs.
• Proactively identify and mitigate risks to ensure timely achievement of corporate goals with high quality and data integrity.
• Support timely database lock by overseeing monitoring plans and participating in data review and reconciliation efforts.
• Coordinate and present key study metrics including subject enrollment site selection/feasibility and data collection.

Requirements

• Handson experience leading earlystage (firstinhuman to Phase 2) clinical trials.
• Ability to work in a fastpaced environment with minimal formal infrastructure.
• Familiarity with US and EU regulatory and data quality standards including GCP and ICH guidelines.
• Excellent communication and interpersonal skills for effective collaboration with internal and external stakeholders.
• Proactive and strategic mindset with a drive for improvement and initiative.
• Willingness to work inoffice (hybrid) in Copenhagen preferred.

What can we offer you

A great place to work where you will get the chance to push your career to the next level global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients saving lives and aiming to increase their quality of life by supporting our clients.

• Career progression opportunities
• Excellent supportive highly experienced local manager
• Great positive team culture with a health work/life balance