Senior Clinical Trial Manager

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee the initiation, execution, and closure of clinical studies, with a focus on late-stage COPD trials.

• Independently handle clinical trial operations, including collaboration with CROs, central laboratories, biomarker and specialty labs, and clinical trial sites.

• Lead and facilitate cross-functional internal study team meetings and manage deliverables.

• Identify, evaluate, and select clinical trial sites and investigators in partnership with CROs; maintain key relationships.

• Supervise the daily execution of trials, encompassing site startup, patient enrollment, monitoring, compliance, and data-flow metrics.

• Organize and facilitate meetings for investigators, kick-off sessions, monitoring-training, CROs, and vendors.

• Develop and review informed consent forms, study guidelines, operational manuals, and training materials.

• Contribute to the creation of protocols, amendments, case report forms (CRFs), IRB/Ethics applications, and recruitment materials.

• Oversee clinical study budgets and timelines, ensuring alignment with program objectives.

• Lead monitoring oversight visits, collaborating with CROs, investigators, and site staff to discuss outcomes and findings.

• Review study reports and metrics to ensure timely collection of clinical data, samples, and lab results.

• Collaborate on the development of standard operating procedures (SOPs) and standardized clinical business tools.

• Create action plans that address protocol compliance, safety, data, and administrative challenges.

• Maintain and supervise the Trial Master File.

• Work with QA and cross-functional teams to ensure inspection readiness, TMF completeness, audit preparedness, and compliance with GCP, SOPs, and regulatory standards.

• Prepare trial-data presentations for management reviews, scientific meetings, and advisory boards.

• Mentor and train junior staff members.

• Report to the Director of Clinical Operations and collaborate with teams in Data Management, Clinical Supply, Regulatory Affairs, and Preclinical Discovery & Development.

• Propel clinical-stage protein medicines forward using AI-driven generative biology.

⛳️ Requirements

• A Bachelor’s degree is required; an advanced scientific degree is preferred.

• Over 8 years of experience in clinical operations.

• A minimum of 4 years in late-stage trial operations with a sponsor company.

• Experience across various therapeutic areas; expertise in respiratory indications is highly advantageous.

• Required experience in overseeing CROs, vendors, and laboratories.

• Self-motivated individual capable of thriving in a fast-paced environment.

• Innovative problem solver with exceptional communication and public speaking abilities.

• Strong interpersonal and organizational skills, with a keen attention to detail and the ability to engage with individuals at all levels of the team.

• Willingness to travel up to 30% of the time, both domestically and internationally.

• Comprehensive knowledge of Good Clinical Practice (GCP).

• Familiarity with FDA, EMA, and MHRA regulatory requirements is a plus.

🏝️ Benefits

• Annual bonus.

• Equity compensation.

• Competitive benefits package.