Clinical Trial Manager II (Phase III )

Odyssey Therapeutics; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Odyssey Therapeutics in Boston, MA is seeking a Clinical Trial Manager II to lead the clinical delivery of multi-site Phase III studies. You will oversee budgets, monitoring plans, and vendor relationships while driving enrollment and study start-up activities.

You will mentor operations staff, manage timelines, ensure ICH GCP compliance, and partner with internal and external stakeholders to mitigate risks. Office-based with travel 25-35%.

Qualifications

• Must have Phase III global trial experience managing multi-site regions.
• Onsite monitoring experience is required.
• Strong leadership and mentoring abilities.
• Proven collaboration, communication, and organizational skills.

Responsibilities

• Oversee the clinical portion of study budgets and monitoring plans.
• Train operations team members and drive enrollment and start-up activities.
• Liaise with internal and external stakeholders and manage vendor relationships.
• Ensure study documentation quality and regulatory compliance (ICH GCP).
• Monitor study milestones, timelines, and risk mitigation efforts.

Skills

Phase III trials

Onsite monitoring

Leadership & mentoring

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Job description

Odyssey Therapeutics is propelling drug development beyond what is now possible to deliver medicines that address critical needs of patients with inflammatory and immunology diseases. We achieve unprecedented speed and efficiency by bringing together a target-centric approach, a toolbox of cutting-edge technologies, and a team of accomplished, world-class drug hunters. By reimagining the drug development process, we are creating a deep and broad drug pipeline that holds the potential to transform human health.

The opportunity:

We are looking for candidates with strong Phase III global clinical trial study experiences, managing multi-sites in global regions.

The Clinical Trial Manager II (CTM II) is responsible for the delivery of all clinical aspects of the study. The CTM II oversees the clinical portion of the budget, develops monitoring plans and tools, train applicable operations team members, drives enrollment and study start-up activities, performs monitoring, liaises with internal and external stakeholders, identifies and mitigates risks that may impact clinical delivery.

Your primary objectives will be:

• Ensure 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 visits, completing all monitoring documentation in a timely manner
• Serve as the clinical point person managing protocol execution, including the oversight of assigned vendors and consultants that are involved with the clinical trial
• Participate in program strategy meetings, ad hoc clinical operations’ initiatives and programs
• Assist in the preparation and review of clinical documentation such as the informed consent, clinical protocols, Investigator’s Brochure, and other study documentation
• Participate in the request and review of scope of works, budgets, vendor performance, and issue resolution
• Establish study milestone and ensure accurate tracking and reporting of study metrics and timelines
• 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
• Manage direct reports and monitor assigned activities as required

About you:

• Must have strong Phase III global clinical trial study experiences, managing multi-sites in global regions.
• Onsite Monitoring experience
• Bachelor’s degree in life sciences, health, or other relevant field of study required
• Minimum 3 years of experience required with at least 1 year as a clinical trial managerExperience in biotech
• 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
• Expected travel: 25-35%

Disclosure Statement

The salary range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. Actual base salary pay will be based on several factors, including skills, competencies, experience, and other job-related factors permitted by law.