Senior Clinical Trial Lead — Global Ops (Onsite, Equity)

City Therapeutics; Cambridge (MA); Vor Ort; USD 164.000 - 185.000; Vollzeit

Benefits dieser Stelle

Health, dental, vision insurance

Life insurance

HSA/FSA accounts

401(k) with company match

Zusammenfassung

City Therapeutics is seeking a Senior Clinical Trial Manager to lead cross‑functional teams and manage the operational delivery of Phase 1 dose‑escalation through later‑phase trials. You will coordinate with CROs, investigators, and internal stakeholders to ensure quality, timelines, and budget adherence in a fast‑paced biotech environment.

You will partner with legal and finance on budgeting and contracting, oversee TMF and trial registries, and drive inspection readiness while maintaining

Qualifikationen

• Minimum of 5+ years of experience in clinical trial management or biotech/pharma industry.
• Strong project management and proactive problem-solving skills.
• Excellent interpersonal, communication, and organizational abilities.
• Deep knowledge of clinical trial regulations (ICH-GCP, FDA, EMA).

Aufgaben

• Plan and manage operational aspects of clinical trials from start-up to close-out.
• Lead cross-functional study teams and coordinate updates to internal leadership.
• Support protocol development, site and country selection, vendor identification, and budgeting.
• Review and approve key study documents (informed consent, study management plans, reports).
• Maintain relationships with vendors and CROs and monitor performance and issues.
• Manage study risks, ensure GCP compliance, and support inspections and CAPAs.
• Oversee budgeting and site contracting with legal and finance teams and monitor invoices.
• Ensure TMF completeness and timely trial registry updates (e.g., ClinicalTrials.gov).
• Identify process improvements to drive efficiency and align with strategic goals.

Kenntnisse

Project management

Cross-functional leadership

Communication

Vendor management

Regulatory knowledge

Ausbildung

Bachelor's degree in life sciences

Tools

TMF management

Jobbeschreibung

City Therapeutics is seeking a Senior Clinical Trial Manager to lead cross‑functional teams and manage the operational delivery of Phase 1 dose‑escalation through later‑phase trials. You will coordinate with CROs, investigators, and internal stakeholders to ensure quality, timelines, and budget adherence in a fast‑paced biotech environment.

You will partner with legal and finance on budgeting and contracting, oversee TMF and trial registries, and drive inspection readiness while maintaining