Open to opportunities

Rachid Akiki

@rachidakiki

Message

Clinical trial manager leading end-to-end global execution across sponsor and CRO teams.

United States

Message

What I'm looking for

I’m looking for a remote-eligible leadership role where I can own global clinical program execution end-to-end—strengthening GCP/FDA/EMA compliance, monitoring readiness, and cross-functional delivery while building trusted sponsor relationships.

I’m a clinical trial manager and operations leader with end-to-end accountability for global clinical program execution across CRO and sponsor settings. I own site management, sponsor communications, monitoring compliance, cross-functional study coordination, and budget tracking.

In my current role as Head of Regulatory & Clinical Affairs, I lead SOP governance, quality systems, monitoring compliance, health authority communications, and inspection readiness. I also serve as the operational point of contact for clinical and regulatory sponsor communications, keeping cross-functional teams aligned from day one.

Previously, I built SOP frameworks, escalation models, and operational governance processes as Chief Operating Officer within a decentralized healthcare platform, and I led full-service CRO programs as a Senior Project Director—delivering multiple international programs ahead of milestone targets and under budget. As a sponsor-side Project Director at Massachusetts General Hospital, I managed Phase I/II programs with IRB submissions, safety oversight, TMF documentation, and audit-ready GCP compliance, including $4M DOD grant accountability.

Experience

Work history, roles, and key accomplishments

Current

Head of Regulatory & Clinical Affairs

Current

2San Inc.

May 2024 - Present (2 years 1 month)

Led the regulatory and clinical functions, establishing SOP governance, quality systems, monitoring compliance, and inspection readiness. Acted as the operational point of contact for clinical and regulatory sponsor communications and cross-functional study coordination.

Quality Systems Inspection Readiness ETMF CTMS

Medical Director

VRWorkout

Jan 2022 - Jan 2024 (2 years)

Supported clinical strategy and contributed to remote team operational workflow development. Helped translate clinical oversight needs into practical, repeatable operational processes for the digital health team.

Clinical Strategy Clinical Oversight Remote Operations Workflow Development Cross functional Coordination

Chief Operating Officer

Book Doctors

Jan 2020 - Jan 2024 (4 years)

Led multi-functional clinical and operational teams for a decentralized healthcare platform, building SOP frameworks, escalation models, and operational governance. Managed sponsor and external partner relationships and served as the primary escalation point for cross-functional decision-making.

Clinical Operations Leadership SOP Development Escalation Management Operational Governance

Senior Project Director

Biorasi, Inc.

Jan 2019 - Jan 2020 (1 year)

Served as primary clinical program lead at a full-service CRO, managing site oversight, CRA coordination, monitoring plan compliance, TMF documentation, and protocol deviation management. Owned study budget compliance and change processes, coordinated cross-functional study teams, and delivered multiple international programs ahead of milestone targets and under budget.

Site management TMF Budgeting Change Order Management

Project Director, Clinical Trials

Massachusetts General Hospital

Jan 2015 - Jan 2018 (3 years)

Managed Phase I/II sponsor-side clinical programs, including IRB submissions, site coordination, safety oversight, TMF documentation, and cross-functional study team management. Owned $4M DOD grant accountability for procurement and milestone reporting while maintaining GCP-compliant, audit-ready documentation across concurrent programs.

IRB Submission TMF Management GCP Compliance Audit Readiness Grant Procurement Oversight