Remote Senior Clinical Trial Manager - Immunology

Beeline Medicines; United States; Remoto; USD 150.000 - 195.000; Tempo pieno

Vantaggi offerti da questo lavoro

Discretionary bonus

Long-term incentive award

Hybrid work schedule

Descrizione del lavoro

Beeline Medicines is seeking a Senior Clinical Trial Manager to lead global, complex immunology studies and drive operational excellence. You will partner with cross‑functional teams and CROs to ensure on‑time delivery, regulatory compliance, and inspection readiness.

Strong leadership and remote collaboration are essential. The role emphasizes overseeing study timelines, risk mitigation, and data readiness while supporting regulatory submissions and process improvements.

Competenze

• Bachelor’s degree in life sciences or related field (advanced degree preferred)
• Minimum 5 years of experience in clinical operations in biopharmaceuticals, with 3+ years in a Senior CTM or leadership role
• Proven track record managing global, multi-center trials in immunology/autoimmune diseases
• Experience with biologics/monoclonal antibodies/advanced therapies
• Familiarity with GCP/ICH guidelines and regulatory requirements
• Experience in early-to-late-stage programs, including pivotal trials

Mansioni

• Lead strategic planning and execution of global Phase 1–4 trials in immunology indications
• Serve as main operational point of contact for internal and external partners
• Oversee CRO/vendor selection, scope, budgets, contracting and oversight
• Drive site feasibility, activation, enrollment strategies and site management
• Develop study timelines, risk mitigation plans, and tracking tools
• Collaborate on protocol development, CRF design, ICF review, and operational study plans
• Ensure compliance with GCP/ICH and local regulations
• Identify and mitigate operational risks and issues
• Oversee data collection, database readiness, and data review
• Contribute to regulatory filings and inspection readiness
• Provide leadership and mentorship to Clinical Operations team
• Lead process improvements within Clinical Operations
• Perform other duties as assigned

Conoscenze

Clinical operations

Global trials leadership

GCP/ICH knowledge

CTMS

EDC

eTMF

Risk-based monitoring

Independent work

Formazione

Bachelor's degree in life sciences

Advanced degree preferred

Strumenti

CTMS

EDC

eTMF

Descrizione del lavoro

Beeline Medicines is seeking a Senior Clinical Trial Manager to lead global, complex immunology studies and drive operational excellence. You will partner with cross‑functional teams and CROs to ensure on‑time delivery, regulatory compliance, and inspection readiness.

Strong leadership and remote collaboration are essential. The role emphasizes overseeing study timelines, risk mitigation, and data readiness while supporting regulatory submissions and process improvements.