Clinical Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership of the operational execution of the US clinical program, which includes the FDA pivotal trial and a randomized pragmatic trial.

• Supervise European MDR investigations conducted from Berlin.

• Lead the trial start-up process, encompassing site selection, agreements, budgets, IRB submissions, site initiation, and training.

• Facilitate enrollment and ensure protocol adherence across sites in collaboration with investigators and site coordinators.

• Manage the monitoring strategy and perform both remote and on-site monitoring visits.

• Oversee contract monitors.

• Handle study budgets, timelines, and risk registers, providing updates to the Chief Medical Officer.

• Operate the foundational infrastructure, which includes eTMF, EDC, data cleaning, and managing protocol deviations.

• Ensure readiness for FDA BIMO and IRB audits and inspections.

• Maintain sponsor Standard Operating Procedures (SOPs).

• Support European investigations and ensure regulatory compliance under ISO 14155 and MDR.

• Author and update SOPs and work instructions related to clinical operations, monitoring, and data management.

• Coordinate with academic partners and specialized vendors.

• Collaborate with the Chief Medical Officer, Clinical Research Lead, regulatory teams, product teams, and R&D teams.

• Assist in the growth of the clinical team.

⛳️ Requirements

• A degree in life sciences, nursing, medicine, biomedical engineering, or a related discipline.

• A minimum of 5 years of experience in clinical research, including at least 3 years with US FDA-regulated devices.

• Knowledge of SaMD clinical trials.

• Practical experience with the entire IRB submission lifecycle, including preparation and submission of packages and amendments to documents such as the Clinical Investigation Plan (CIP) and Informed Consent Form (ICF).

• Direct experience managing a US multicenter trial from start-up through enrollment and closure, on the sponsor side, without utilizing a full-service CRO.

• Familiarity with 21 CFR Parts 812, 50, 56, and 11, ICH-GCP, ISO 14155, and HIPAA regulations.

• Hands-on experience with EDC and eTMF systems.

• Ability to solve problems in a structured manner and prioritize tasks effectively under changing timelines.

• Strong stakeholder management skills across academic sites, health systems, and senior Key Opinion Leaders (KOLs).

• A steadfast commitment to patient safety, data integrity, and inspection readiness.

• Proficiency in English.

• Authorization to work in the US.

🏝️ Benefits

• Meaningful equity opportunities.

• Fully remote working arrangement within the US.

• Up to 30% travel expected in the first 12 months, with less thereafter.

• Occasional visits to the Berlin office.

• Direct involvement with leading US cardiology centers and the FDA Breakthrough Devices process.