Sr. Clinical Trial Manager

Clinovo; Cambridge (MA); On-site; USD 110,000 - 145,000; Full time

Job summary

Clinovo is seeking a Clinical Trial Manager to lead trials from startup through closeout in a fast-paced biotech setting. The role emphasizes operational oversight, budgeting, timelines, and regulatory compliance with a strong emphasis on collaboration across Clinical Operations, Data Management, Biostatistics, and Regulatory Affairs.

The ideal candidate will have 5+ years of clinical operations experience, a Life Sciences-related degree, and a proven ability to manage multiple studies while

Qualifications

• Proven ability to manage multiple studies and timelines.
• Strong collaboration across Clinical Operations, Biostatistics, Data Management, Safety, and Regulatory.
• Excellent planning, documentation, and quality oversight aligned with ICH-GCP.

Responsibilities

• Contribute to study planning activities, including protocol implementation and startup efforts in partnership with Clinical Operations leadership.
• Support creation, review, and maintenance of essential study documentation (protocols, ICFs, manuals, training materials).
• Ensure compliance with ICH-GCP and internal procedures throughout the study lifecycle; act as operational liaison to CROs and vendors.
• Monitor study progress: site performance, enrollment, monitoring activities, and risk mitigation; escalate issues as needed.
• Assist with budgets, timelines, forecasting, and contract/SOW development; promote cross-functional communication.
• Support inspection readiness, audit responses, and process improvements; collaborate with Data Management for data review and cleaning.
• Maintain complete Trial Master File documentation and contribute to CSR development.

Skills

Project management

Communication

Organizational skills

Cross-functional leadership

Vendor management

Education

Bachelor's degree in Life Sciences/Nursing/Pharmacy or related

Job description

The Clinical Trial Manager (CTM) plays a key role in the successful execution of clinical research studies, providing operational leadership from study initiation through final closeout. This position is well-suited for a highly organized professional who excels in a collaborative environment, proactively addresses challenges, and thrives in a growing, fast-paced biotechnology setting. The CTM will manage relationships with CROs and vendors, oversee study timelines and budgets, and ensure that clinical trials are conducted efficiently, compliantly, and with a high standard of quality.

Key Responsibilities

Clinical Trial Planning & Management

• Contribute to study planning activities, including protocol implementation, startup efforts, site feasibility, selection, and activation in partnership with Clinical Operations leadership
• Support the creation, review, and maintenance of essential study documentation, including protocols, informed consent forms, study manuals, and training materials
• Ensure clinical studies comply with applicable regulations, ICH-GCP standards, and internal procedures throughout the study lifecycle
• Act as the primary operational liaison for contract research organizations (CROs) and external service providers
• Monitor study progress, including site performance, patient enrollment, monitoring activities, and risk mitigation efforts
• Evaluate vendor deliverables, performance indicators, and quality metrics, identifying and escalating concerns when necessary

Clinical Operations Leadership

• Assist with management of study budgets, timelines, forecasting activities, and support the development of contracts and statements of work
• Facilitate cross-functional study team meetings and promote effective communication among Clinical Development, Biostatistics, Data Management, Safety, Regulatory Affairs, and other stakeholders
• Support inspection readiness initiatives and participate in audit responses, corrective actions, and process improvements

Data Management & Quality Oversight

• Collaborate with Data Management teams to support database development, data review, query resolution, and data cleaning activities
• Review clinical data outputs, protocol deviations, and safety-related documentation to ensure quality and compliance
• Maintain complete, accurate, and inspection-ready Trial Master File (TMF) documentation

Study Closeout Activities

• Coordinate site closure activities, reconciliation processes, and final study deliverables
• Contribute to Clinical Study Report (CSR) development and capture lessons learned to support continuous improvement initiatives

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline; advanced degree preferred
• Minimum of 5 years of clinical operations experience within the biotechnology, pharmaceutical, or clinical research industry, including direct management of clinical studies
• Strong knowledge of clinical trial operations, ICH-GCP guidelines, regulatory requirements, and vendor oversight practices
• Prior experience working in startup, small biotechnology, or growth-stage organizations is highly desirable
• Demonstrated ability to manage multiple projects simultaneously, identify risks early, and work independently while collaborating effectively with senior leadership
• Excellent project management, communication, organizational, and cross-functional leadership skills
• Proven ability to build productive partnerships with internal teams, investigators, CROs, and external vendors