Clinical Trial Manager/Senior Clinical Trial Manager

The role

The Clinical Trial Manager/Senior Clinical Trial Manager will serve as the primary operational lead for a study and lead the cross-functional team for execution. This person provides operational leadership to ensure project milestones are delivered on time, within budget, and in compliance with regulations.

What you will do

• Lead all operational aspects and progress of clinical trials
• Serve as an escalation point and resource for study team and investigative sites
• Facilitate and review the site feasibility process and oversee site selection
• Oversee subject recruitment and retention strategy
• Provide operational input for study documents including protocol and ICFs
• Develop protocol training materials for CRAs and site-facing materials
• Oversee study teams in review of clinical data
• Lead the assigned clinical monitoring team to deliver on study timelines
• Oversee monitoring visit schedule and review site monitoring visit reports
• Participate in clinical vendor selection and oversee vendor activities

Required qualifications

• Bachelor's degree
• At least 5 years clinical research experience in a biotech/pharmaceutical company or CRO for Clinical Trial Manager level
• At least 7 years clinical research experience in a biotech/pharmaceutical company or CRO for Senior Clinical Trial Manager level
• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations / ICH / GCP guidelines
• Ability to work on complex or multiple projects and exercise independent judgment
• Strong attention to detail, time management and excellent organizational skills
• Strong interpersonal skills and communication skills
• Ability to problem solve, delegate appropriate tasks, work within a team environment and mentor junior team members
• Excellent sense of urgency to deliver at/surpass study conduct targets
• Strong leadership skills, self-motivated, adaptable to a dynamic environment
• Comfortable multi-tasking in a fast-paced small company environment
• Willingness to travel as needed, up to 20%

Nice to have

• Scientific background
• Prior small company experience
• 1+ years management experience
• Energetic candidates with a desire to think outside the box

Benefits

• Annual bonus
• Significant equity
• Generous benefits package

About the company

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. Their neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine.