Clinical Trial Manager I

Odyssey Therapeutics • Boston, MA

11h

About The Position

As a Clinical Trial Manager I, you will be at the heart of our clinical research efforts, responsible for the end-to-end delivery of all clinical aspects of assigned studies. You will be a key driver of trial success, from accelerating study start-up and managing enrollment goals to ensuring meticulous site/vendor oversightand data quality. You'll serve as the primary liaison between internal teams and external partners, including study sites and vendors, to ensure seamless communication and execution.

This role requires a proactive professional who can identify and mitigate potential risks that may impact clinical delivery and timelines. By taking ownership of these critical responsibilities, you will ensure our clinical trials are conducted with the highest standards of quality and compliance, ultimately contributing to the successful development of life-changing therapies.

Requirements

• Bachelor’s degree in life sciences, health, or other relevant field of study
• 2-5 years of experience
• Experience in biotech required
• Monitoring experience
• Strong knowledge and practical application of clinical trial operations
• Excels in a fast-paced, high-growth company environment with minimal direction and a high degree of independence and is able to adjust workload based on changing priorities
• Strong skills in collaboration, communication, organization, attention to detail and multi-tasking
• Demonstrated leadership, problem-solving, conflict resolution, and team building skills
• Ability to handle multiple projects and utilize judgement to prioritize tasks

Nice To Haves

• Ability to travel 20-30% as required for oversight

Responsibilities

• Ensuring quality of the trial master file through content (QC) review of submitted documents, applying metadata and finalizing documents and liaise with project teams to resolve any issues identified with submitted documents
• Provide monitoring oversight including assisting with the development of the clinical monitoring plan, performing study monitoring audit visits, and reviewing data entered into EDC and EDC reports
• Serve as the clinical point person managing protocol execution, including the oversight of assigned vendors and consultants that are involved with the clinical trial
• Participates in ad hoc clinical operations’ initiatives and programs
• Ensure study milestones are being met and there is accurate tracking and reporting of study metrics and timelines
• Support the review and tracking of study invoices, initiation and updates to vendor POs and supports finance review as required
• Responsible for executing one or more elements of clinical trials in compliance with ICH GCP, SOPs, and local applicable regulations
• Provide study-specific mentor and training for clinical operation team members
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level