Clinical Trial Manager

Location: Greater Boston Area (Hybrid — 2–3 days/week on site)

Study Focus: Phase 1, Multinational (U.S., Middle East, Africa)

Therapeutic Areas: Rare Disease, Hematology, Oncology

Our client, an early-stage biotechnology company based in the Boston area, is seeking an experienced Clinical Trial Manager (CTM) to provide operational leadership and oversight for a global Phase 1 study that is preparing to start. This position will play a key role in driving study start-up, vendor and CRO management, and cross-functional coordination in a lean, fast-moving biotech environment.

Key Responsibilities

• Lead day-to-day management and operational oversight of a Phase 1 study, ensuring quality, compliance, and delivery against timelines.
• Manage and oversee global CROs, vendors, and site operations across the U.S., Middle East, and Africa.
• Support all study start-up activities, including site initiation, feasibility, budget and contract review, and essential document collection.
• Partner closely with Clinical Operations, Regulatory, and CMC to align study timelines, enrollment goals, and deliverables.
• Oversee sample management workflows (biological sample tracking, reconciliation, and shipment logistics) in coordination with central labs and CRO partners.
• Ensure trial master file (TMF) completeness and quality in alignment with GCP and ICH guidelines.
• Manage site communications and issue resolution, escalating operational or vendor risks proactively.
• Contribute to study plans, monitoring plans, risk management plans, and study reports.
• Track key performance metrics (enrollment, monitoring, data entry, query resolution) and maintain operational dashboards.

Qualifications

• Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
• 5–8+ years of clinical operations experience with at least 3 years as a CTM or equivalent role.
• Demonstrated success managing Phase 1 studies and working across multiple regions or time zones.
• Strong background in CRO/vendor oversight and familiarity with global study management.
• Knowledge of sample management processes and best practices for biologic sample tracking.
• Hands-on experience with study start-up, site activation, and regulatory submissions.
• Proven ability to thrive in a small biotech setting — adaptable, resourceful, and comfortable wearing multiple hats.
• Strong communication and organizational skills; capable of building relationships across diverse internal and external stakeholders.
• Deep understanding of ICH-GCP, FDA, and EMA guidelines for early-phase clinical research.