Clinical Trial Manager

Location: Hybrid | Boston, MA

Employment Type: Full-time cAMPfield is a clinical-stage biopharmaceutical company focused on developing well-tolerated and highly effective oral medicines, founded and led by industry veterans with success developing therapies for immune-mediated inflammatory diseases, including inflammatory bowel disease (IBD).

About the Role

The Clinical Trial Manager (CTM) is responsible for supporting the day-to-day management of clinical studies from startup through closeout. This role is ideal for someone who is energized by cross-functional collaboration, proactive problem-solving, and the pace of an emerging biotech. The CTM will oversee CROs, vendors, timelines, budgets, and ensure inspection-ready execution across all phases of the trial.

Key Responsibilities

Study Planning & Execution

• Support the overall operational planning, study startup, site selection, and activation activities under the direction of senior Clinical Operations leadership.
• Assist in the development and review of core study documents (protocols, ICFs, etc.) and drive the development of study plans, manuals, and training materials.
• Ensure studies are conducted in accordance with ICH-GCP, regulatory requirements, and internal SOPs.

CRO & Vendor Oversight

• Serve as the day-to-day operational contact for CROs and external vendors, supporting escalations to senior Clinical Operations leadership as appropriate.
• Oversee monitoring activities, enrollment performance, site engagement, and risk mitigation.
• Review vendor deliverables, KPIs, and quality metrics; escalate issues proactively.

Clinical Operations Leadership

• Assists with the overall management of study timelines, budgets, and forecasting; support contract and SOW development.
• Lead cross-functional study team meetings and ensure alignment across Clinical Development, Biometrics, Safety, and Regulatory.
• Support inspection readiness and contribute to audit responses and CAPAs.

Data & Quality Oversight

• Partner with Data Management on database build, data cleaning, and query resolution.
• Review clinical data listings, safety narratives, and protocol deviations.
• Ensure high-quality documentation and TMF completeness.

Study Closeout

• Oversee site closeout, reconciliation activities, and final study reporting.
• Contribute to CSR development and lessons-learned processes.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• 5+ years of clinical operations experience in biotech/pharma, with direct CTM-level ownership of clinical studies.
• Strong understanding of ICH-GCP, clinical trial processes, and vendor oversight.
• Experience working in small or emerging biotech environments strongly preferred.
• Ability to manage multiple priorities, anticipate issues, and comfortable operating with a high degree of autonomy as well as under the guidance of senior team members.
• Excellent communication, organization, and cross-functional leadership skills.

What We Offer

• The opportunity to play a foundational role in a mission-driven biotech start-up.
• A collaborative, science-driven culture where operational excellence is valued.
• The ability to shape the office environment and operational backbone of a growing company.
• Competitive compensation and benefits.