Clinical Trial Manager II (Phase III )

About the role

The Clinical Trial Manager II (CTM II) is responsible for the delivery of all clinical aspects of the study. The primary objectives include ensuring quality of the trial master file through content review, providing monitoring oversight, managing protocol execution, participating in program strategy meetings, assisting in the preparation and review of clinical documentation, and managing direct reports.

Responsibilities

• 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
• Absorb and review scope of works, budgets, vendor performance, and issue resolution
• Establish study milestone and ensure accurate tracking and reporting of study metrics and timelines
• Execute one or more elements of clinical trials in compliance with ICH GCP, SOPs, and local applicable regulations
• Manage direct reports and monitor assigned activities as required

Requirements

• 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 manager
• Experience in biotech
• Strong knowledge and practical application of clinical trial operations
• Excelling in a fast-paced, high-growth company environment with minimal direction and a high degree of independence and ability 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

Qualifications

• Ability to handle multiple projects and utilize judgement to prioritize tasks

Skills

• Ability to handle multiple projects and utilize judgement to prioritize tasks

Benefits

N/A

Pay

120,490 - 180,736 USD per year (Boston)

Schedule

N/A