What are the responsibilities and job description for the Senior Clinical Trial Manager position at Beacon Hill?
The Senior Clinical Trial Manager (CTM) is responsible for the planning, execution, and oversight of one or more clinical trials across all phases of development. Acting as a key operational lead, this role ensures that studies are delivered on time, within budget, and in compliance with regulatory and quality standards. The Sr. CTM will collaborate cross-functionally, manage external partners, and contribute to process improvements within the Clinical Operations function.
Key Responsibilities:
- Serve as the primary operational lead for assigned clinical trials, overseeing all aspects of study execution from start-up through close-out.
- Manage CROs and external vendors to ensure adherence to timelines, budgets, and quality standards.
- Lead cross-functional study teams to ensure alignment on objectives, deliverables, and risk mitigation strategies.
- Oversee the development and review of study-related documentation, including protocols, informed consent forms, monitoring plans, and investigator materials.
- Monitor study progress, including site performance, data quality, and protocol compliance; identify and resolve operational issues proactively.
- Ensure ongoing inspection readiness and proper maintenance of the Trial Master File.
- Collaborate with internal stakeholders (e.g., Regulatory, QA, Data Management, Clinical Development) to maintain compliance with GCP, ICH, and applicable global regulations.
- Support development and implementation of departmental best practices and process improvements.
- Mentor and provide guidance to junior team members as appropriate.
Required Qualifications:
- Minimum of 7 years of experience in clinical research, including direct oversight of CROs and vendors.
- Demonstrated ability to lead cross-functional study teams and manage clinical programs independently.
- Strong understanding of GCP, ICH guidelines, and regulatory requirements for global clinical trials.
- Excellent problem-solving, organizational, and analytical skills with a proactive approach to issue resolution.
- Effective written and verbal communication skills, including experience presenting to cross-functional stakeholders.
- Ability to manage multiple priorities in a dynamic, fast-paced environment.
- Proficiency in Microsoft Office and familiarity with project management tools (e.g., MS Project, Smartsheet).
- Willingness to travel as needed.
Preferred Qualifications:
- Experience in the biotechnology or pharmaceutical industry preferred.
Education:
- Bachelor’s degree in life sciences or a related discipline; an advanced degree is a plus.