Clinical Trial Manager (CTM or Sr. CTM)

Duties and Responsibilities

• Oversees site initiation, subject enrollment, clinical monitoring, compliance at clinical sites, and metrics management with CROs, central labs, and external vendors.
• Ensures high-quality execution throughout clinical trial initiation, conduct, and closure.
• Manages study budgets, contracts with vendors, and negotiates agreements to track and control costs effectively.
• Guides cross-functional teams in achieving study timelines, strategies, goals, and quality benchmarks.
• Evaluates and ensures effective oversight of Contract Research Organizations (CROs) and other vendors, fostering strong partnerships and accountability.
• Communicates effectively with study team and sites to maintain project momentum, direction, and team effectiveness.
• Updates stakeholders on trial progress to align expectations, priorities, and deliverables.
• Contributes to study-level budget development and takes responsibility for budget management.
• Identifies and addresses risks associated with clinical studies and investigator sites, implementing corrective actions or escalations as needed.
• Leads operational activities detailed in study plans, SOPs, and other study-related documents.
• Reviews / contributes to critical study documents, including protocols, manuals, informed consent forms, and operational materials.
• Assesses monitoring visit reports to verify site training adequacy and resolve any outstanding issues promptly.
• Leads study team’s cross-functional vendor oversight efforts.

Requirements and Qualifications

• Minimum of a bachelor’s degree in a scientific or health-related discipline.
• Minimum of 3+ years of Clinical Operations and Clinical Trial Management experience at a contract research organization, biotech or pharmaceutical company preferably in early to mid-phase oncology.
• Proven leadership skills managing cross-functionally in a matrix environment.
• Demonstrated ability to build strong relationships with internal / external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
• Mature, level-headed and organized with a can-do disposition.
• Strong verbal and written communication skills with ability to communicate and work productively in a team environment.
• Proficient computer skills i.e. Microsoft Project, Word, PowerPoint, and Excel.
• Proven ability to multi-task and work collaboratively as well as independently.
• Able to organize and manage multiple priorities required.