Clinical Trial Manager

Company Overview

Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s lead program in clinical development is Pociredir, a small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease (SCD).

Description

Reporting to the Director of Clinical Operations, the Clinical Trial Manager (CTM) is responsible for the planning, execution, and oversight of global clinical trials, ensuring high-quality delivery in alignment with ICH-GCP, regulatory requirements, and corporate objectives. This role provides day-to-day operational leadership, manages CROs and vendors, and contributes to the development of processes that support the growth of the Clinical Operations function.

In keeping with the Fulcrum culture, this position will be onsite requiring a minimum 50% on-site presence in the Fulcrum office in Cambridge, MA.

Responsibilities

· Manage daily clinical trial operations across all trial phases (startup through closeout), ensuring adherence to timelines, budget, and quality standards.

· Lead planning, implementation, and execution of global clinical trials, coordinating cross-functional team activities and CRO resources.

· Oversee CROs and vendors, monitor performance metrics, and ensure timely and high-quality deliverables.

· Develop and contribute to patient recruitment plans, enrollment projections, and supporting documentation.

· Lead study-specific meetings, including internal team meetings, CRO/vendor meetings, and Investigator Meetings.

· Provide input on key study documents including protocols, ICFs, eCRFs, monitoring conventions, and edit checks.

· Deliver study-specific training to CRO staff and internal team members as needed.

· Track study timelines, enrollment, protocol deviations, data trends, and sample management in partnership with Data Management and Clinical Development.

· Support risk identification, mitigation planning, and contribute to Risk-Based Quality Management and Operational Excellence initiatives.

· Maintain inspection readiness and ensure compliance with SOPs and regulatory standards.

· Assist in the development and management of study budgets; review and approve clinical vendor invoices.

· Prepare regular study updates, presentations, and risk assessments for senior leadership.

· Mentor and provide oversight for junior Clinical Operations staff, including CTAs and Sr. CTAs.

· Contribute to process improvement initiatives, development of SOPs, and operational best practices for the Clinical Operations department.

Qualifications

· Bachelor’s degree in a scientific or health-related field required; Master’s or PhD preferred. Equivalent work experience considered.

· 5 years related experience with a Bachelor’s degree, 3 years with a Master’s degree, or PhD with no experience; or equivalent experience.

· Minimum 2 years managing clinical trials.

· Experience managing global clinical trials across Phase I–III strongly preferred.

· Strong knowledge of ICH-GCP and global regulatory requirements.

· Experience in biotech/pharma environment required.

· Ability to manage multiple tasks in a fast-paced, matrixed environment.