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Hussa Al Othman

@hussaalothman

Message

I lead global clinical studies across medical devices, rare disease, and multi-region delivery.

Germany

Message

What I'm looking for

I'm open to permanent, interim, and contract clinical operations leadership opportunities, leading global studies, building teams, and managing CROs and vendors across medical devices, rare disease, and diagnostics.

I'm currently leading Edwards Lifesciences' PROACTIVE HF2 / Cordelia global study, delivering an AI-enabled preventive program for 1,650+ patients across the EU, UK, and US.

I coordinate Clinical Affairs, Medical Affairs, R&D, engineering, and Quality while engaging FDA, BfArM, and UK authorities. I also direct CRAs, CTAs, and interns, with responsibility for timelines, delivery, onboarding, mentoring, and performance development.

At Occlutech, I owned clinical operations strategy and delivery for three concurrent global investigations and built a Class III device clinical investigation from concept through execution across Europe, APAC, and Australia. I selected, contracted, and performance-managed seven international CROs and vendors while managing budgets up to USD 500K.

My experience also includes multinational rare disease programs at CENTOGENE, including securing GCC ethics approvals for Sarepta's Duchenne Muscular Dystrophy program. I bring an 8+ year foundation in global study delivery, ICH-GCP, ISO 14155, EU MDR 2017/745, inspection readiness, and clinical operations team leadership.

Experience

Work history, roles, and key accomplishments

Current

Clinical Operations Lead

Current

Edwards Lifesciences GmbH

Feb 2025 - Present (1 year 7 months)

Lead the PROACTIVE HF2 / Cordelia global study across the EU, UK, and US, directing CRAs, CTAs, and interns. Coordinate cross-functional teams and engage with regulatory authorities.

Clinical Operations Study Leadership CRO Management ICH GCP ISO 14155 EU MDR CTMS ETMF EDC Microsoft Project

Senior Clinical Project Manager

Occlutech GmbH

Jan 2024 - Jan 2025 (1 year)

Owned clinical operations strategy and delivery for three concurrent global investigations. Created the global PDA Clinical Investigation from concept, managed CROs and vendors, and led a 6-person team.

Clinical Operations Project Management CRO Management Vendor Management Budget Management Team Leadership Risk Management ICH GCP ISO 14155 EU MDR

Clinical Project Manager

Occlutech GmbH

Feb 2021 - Dec 2023 (2 years 10 months)

Managed studies across 20+ countries, leading start-up, feasibility, site activation, and regulatory submissions. Maintained inspection-ready TMF and vendor KPI oversight.

Clinical Operations Study Start Up Feasibility Site Activation Regulatory Submissions TMF Vendor Management ICH GCP ISO 14155 EU MDR

Clinical Project Manager

CENTOGENE GmbH

Sep 2019 - Jan 2021 (1 year 4 months)

Delivered multinational rare disease programs for global pharmaceutical sponsors, managing start-up, submissions, site activation, and vendors. Secured ethics approvals across GCC countries for Sarepta's Duchenne Muscular Dystrophy program.

Clinical Operations Rare Diseases Regulatory Submissions Site Activation Vendor Management ICH GCP ISO 14155 EU MDR