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:- 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
- Experience monitoring
- 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%
The pay range for this role is:
120,490 - 180,736 USD per year (Boston)
