Senior Trial Manager - Remote

Overview

The primary responsibility of the Senior Trial Manager is the management and delivery of clinical trials to our German and/or French clients. As one of the early Lindus Health team members teamwork, integrity and high agency are absolutely essential. A good working knowledge of the regulatory, ethics and clinical operations requirements is a prerequisite. You will be required to work and contribute in an agile and innovative work culture.

In Short

• Lead and manage the day to day running of CTIMP and non-CTIMP clinical trial programs and projects.
• Acts as primary liaison between Lindus Health and the Sponsor.
• Coordinates activities and deliverables of all project partners.
• Accountable for maintenance of project information on a variety of databases and systems.
• Maintains and evaluates project progress.
• Responsible for project management components of inspection readiness.
• Facilitates team training in accordance with protocol and/or project requirements.
• Work closely with the tech and product teams.
• Support business development work with Sponsors and vendors.
• Contribute to our clinical strategy as an early employee of the clinical operations team.

Requirements

• Meaningful experience working on German and/or French clinical trials.
• Strong knowledge of Good Clinical Practice/ICH guidelines.
• More than 4 years' experience managing clinical trials.
• Experienced in study start-up and EC/IRB applications.
• Experience with different software for clinical trials.
• Experience in decentralised/remote trials.
• Experience running multi-site and IND/CTIMP trials.
• Previous startup/biotech experience is a plus.

Benefits

• Unlimited holidays; encouraged to take at least 28 days each year.
• 60 EUR monthly wellness allowance.
• Enhanced Parental Leave: 16 weeks full pay for primary caregiver.
• 1000 EUR Learning and Development allowance each year.
• Regular whole company and team events.
• Access to gym and retail discounts.
• Monthly lunch voucher for remote teams.
• Charity events and fundraising opportunities.