Senior Manager, Clinical Trial Lead

Job Title: Senior Manager, Clinical Trial Lead

Work Location: Massachusetts

Summary:

Seeking an experienced professional to lead and direct the execution of clinical studies across multiple programs, ensuring coordination, management, and operational excellence for assigned clinical trials. This role requires strong leadership, adaptability, and expertise in clinical trial processes, documentation, and vendor oversight.

Responsibilities:

• Lead cross-functional study teams and serve as the primary contact for operational aspects of clinical trials.
• Oversee selection and management of contract research organizations (CROs) and external vendors from study start-up through completion.
• Manage study timelines, budgets, and quality metrics, ensuring alignment with organizational objectives.
• Prepare and review essential study documents, including protocols, informed consent forms, and case report forms.
• Ensure compliance with GCP/ICH guidelines and regulatory requirements, supporting inspection readiness and audit activities.
• Maintain oversight of Trial Master File (TMF) for assigned studies, ensuring completeness and quality.
• Utilize EDC, CTMS, and IRT systems to track study data, milestones, and site activity, and communicate study trends and issues to management.
• Mentor junior team members, manage multiple initiatives, and adapt to shifting priorities in a dynamic environment.

Qualifications:

• Bachelor's degree required.
• 6-8 years of experience in clinical development.
• Experience in a similar role within the biotechnology sector preferred.
• Background in fibrotic disease, rare disease, or related therapeutic areas strongly preferred.
• Hands-on experience with TMF oversight and inspection readiness.
• Familiarity with risk-based monitoring and CRO oversight models.
• Proficiency with EDC, CTMS, and IRT systems (e.g., Veeva, Medidata).
• Demonstrated ability to manage complex schedules and priorities in fast-paced environments.
• Strong influencing skills, ability to work independently and collaboratively within teams.
• Self-motivated, adaptable, and able to lead cross-functional priorities and activities.
• Excellent computer skills, including Microsoft Office Suite (Word, Excel, Outlook).
• Agility to adjust to changing priorities, demands, and timelines with minimal direction.

Published Category: Clinical Operations & Development