Clinical Trial Manager

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

📋 Description

• Oversee the complete delivery of clinical trials, focusing initially on the execution of Phase 1 and providing support for Phase 2 execution.

• Act as the Clinical Operations representative within study teams.

• Lead operational execution at the study level in collaboration with Clinical Development, Regulatory, Data Management, Safety, Statistics, and CMC teams.

• Facilitate alignment and resolve issues effectively.

• Partner with Senior Clinical Trial Managers on intricate studies and expand into greater ownership of studies.

• Manage the conduct of clinical trials, ensuring study-level inspection readiness, TMF integrity, documentation accuracy, investigational product supply, and support for regulatory submissions.

• Perform proactive risk assessments at the study level, prioritizing and escalating issues as necessary.

• Collaborate with senior Clinical Operations leadership on study strategy and execution, problem-solving, and maintaining inspection-ready operational standards.

• Assist in study initiation and ongoing management in accordance with GCP, SOPs, and quality benchmarks.

• Direct study-level operational tasks during audits and regulatory inspections, including preparation, support during inspections, response management, and CAPA implementation.

• Manage CRO and vendor execution, ensuring accountability for quality, timelines, and budget adherence.

• Monitor clinical expenditures and budgets in collaboration with senior team members.

• Compile and present timely, accurate trial status reports for leadership.

⛳️ Requirements

• A Bachelor’s degree is required.

• A minimum of 3 years of experience in independently managing clinical trials across Phases 1–3.

• At least 2 years of experience in a biotech setting managing studies from start-up to maintenance phases.

• Familiarity with clinical research processes, GCP guidelines, and regulatory standards.

• Strong communication and interpersonal skills, particularly in managing external relationships effectively.

• Proficient in Microsoft Suite.

• Willingness to travel occasionally, approximately 20% of the time.

• Strategic planning and organizational capabilities.

• Strong analytical and problem-solving skills.

• Ability to collaborate effectively with external partners in a dynamic, fast-paced environment.

• Keen attention to detail and a commitment to quality standards.

• Aptitude for linking decisions to data integrity and compliance.

• Capability to influence and mentor others in maintaining quality practices.

🏝️ Benefits

• Discretionary annual bonus.

• Comprehensive Medical, Dental, and Vision benefits.

• Short-term and long-term disability coverage.

• Company-paid basic life insurance.

• 401k with company matching.

• Generous paid time off.

• Paid holidays.

• Stock options.

• Option for remote or hybrid work.