Clinical Trials Delivery Lead

allied executive solutions; New York (NY); Hybrid; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

Allied Executive Solutions is seeking a Clinical Trials Project Manager in New York to lead end-to-end trial planning, execution, and oversight in a cross-functional setting. The role ensures on-time, on-budget delivery in line with GCP and regulatory standards.

You will drive startup through close-out, coordinating sponsors, CROs, site personnel, and internal teams while managing risks and timelines across multiple sites. Hybrid work arrangement available.

Qualifikationen

• Bachelor’s degree in life sciences, nursing, public health, or related field (advanced degree a plus).
• 3–5+ years of experience in clinical trial management or clinical research/operations.
• Solid working knowledge of ICH-GCP guidelines and regulatory frameworks (FDA, EMA, etc.).
• Demonstrated experience managing project timelines, budgets, and vendor relationships.
• Strong understanding of clinical trial phases (I–IV) and study designs.
• Excellent organizational, problem-solving, and communication skills.
• Proficiency with CTMS, EDC platforms, and Microsoft Project/Excel.

Aufgaben

• Develop and maintain comprehensive project plans, timelines, budgets, and risk management strategies for assigned clinical trials.
• Manage day-to-day trial operations across all phases: start-up, enrollment, monitoring, and close-out.
• Serve as the primary liaison between sponsors, CROs, investigators, IRBs/ECs, and internal stakeholders.
• Oversee site selection, activation, and performance, ensuring adherence to protocol and regulatory timelines.
• Monitor trial budgets, forecast expenditures, and manage vendor/CRO contracts and deliverables.
• Ensure compliance with ICH-GCP, FDA/EMA regulations, and applicable local laws throughout the trial lifecycle.
• Track and report on enrollment, data quality, and milestone progress to senior leadership and sponsors.
• Identify, assess, and mitigate risks and issues that may impact trial timelines, budget, or quality.
• Coordinate with Data Management, Biostatistics, Regulatory Affairs, and Pharmacovigilance teams.
• Manage TMF and trial documentation to ensure inspection readiness.
• Lead and facilitate internal team meetings, sponsor calls, and investigator meetings.
• Support audits and regulatory inspections as needed.

Kenntnisse

Project management

Regulatory knowledge

Communication

Organizational skills

Problem-solving

Ausbildung

Bachelor's degree in life sciences, nursing, public health, or related field

Advanced degree preferred

Tools

CTMS

EDC platforms

Microsoft Project

Microsoft Excel

Jobbeschreibung

Allied Executive Solutions is seeking a Clinical Trials Project Manager in New York to lead end-to-end trial planning, execution, and oversight in a cross-functional setting. The role ensures on-time, on-budget delivery in line with GCP and regulatory standards.

You will drive startup through close-out, coordinating sponsors, CROs, site personnel, and internal teams while managing risks and timelines across multiple sites. Hybrid work arrangement available.