Associate Director/Director, Clinical Trial Management

Acumen Pharmaceuticals•Newton, MA

96d•Remote

About The Position

The Associate Director/Director, Clinical Trial Management, is responsible for the oversight of the operational planning, execution, and delivery of one or more clinical studies, ensuring quality, timelines, budget, and inspection readiness in accordance with ICH‑GCP, applicable regulations, and Standard Operating Procedures (SOPs). Critical competencies of this role include strategic and operational planning for clinical studies, vendor & CRO oversight with a strong understanding of sponsor responsibilities under ICH-GCP, risk-based thinking and data-driven decision-making using study metrics and dashboards, and people leadership within the Clinical Operations teams. This role reports to the Head of Clinical Operations and may have people management responsibilities within the Clinical Operations team.

Requirements

Bachelor’s degree in life sciences, nursing, pharmacy or related field.
A minimum of 10 years of clinical research/clinical operations experience, including significant experience as a Clinical Trial Manager or equivalent; prior global study leadership and clinical trial experience in CNS strongly preferred.
Demonstrated experience managing phase 1–3 interventional clinical trials, including vendor/CRO oversight and global site management.
Previous experience in resource and people management.
Deep knowledge of ICH‑GCP, relevant regulatory requirements, and clinical trial processes from start‑up to closure.
Proven ability to manage complex timelines and budgets and to lead in a matrix, cross‑functional environment.
Strong leadership, communication, and negotiation skills.
Proficiency with clinical trial systems (e.g., CTMS, eTMF, EDC) and Microsoft Office tools.
This is a remote position. Required to attend company meetings, business, or study-related meetings in person.
Must be willing to travel 25%.
Must be flexible and able to work in a dynamic, fast-paced environment.

Nice To Haves

prior global study leadership and clinical trial experience in CNS strongly preferred

Responsibilities

In collaboration with Clinical Operations lead, lead operational management of assigned clinical studies from protocol synopsis through study close‑out, including start‑up, enrollment, conduct, database lock, and Clinical Study Report (CSR).
Develop and own the operational strategy and study execution plans (e.g., monitoring plan, Trial Master File (TMF) plan, risk management plan) or oversee such activities if outsourced to a Clinical Research Organization (CRO), ensuring alignment with clinical development objectives.
Chair cross‑functional Study Management Team meetings, drive decision‑making, and ensure clear communication of goals, risks, and mitigations to internal and external stakeholders.
Provide oversight of CROs and key vendors, including selection, contract and budget input, performance management, issue escalation, and ensuring compliance with ICH‑GCP and sponsor obligations.
Oversee site feasibility, selection, activation, and performance, ensuring recruitment and retention targets are achieved and supporting co‑monitoring or site visits as needed.
Ensure trial activities are conducted per protocol, Good Clinical Practice (GCP), local regulations, company SOPs, and inspection‑readiness standards, supporting audits/inspections and CAPA implementation.
Manage study timelines, critical path, and key performance indicators; proactively identify risks and implement mitigation and contingency plans.
Contribute to and/or oversee development and review of essential trial documents (protocol, ICFs, study manuals, training materials, study tools).
Provide support or directly manage study budgets and forecasts in collaboration with finance, including vendor invoices, change orders, and cost tracking versus plan.
Provide regular study status updates to Clinical Operations leadership, program leadership and/or senior management, including dashboards, metrics, and issue escalation summaries.
Manage overall performance of the TMF to ensure compliance and inspection readiness, including if TMF management is outsourced to the CRO.
Work with Clinical Operations and other cross functional team members to establish TMF health improvement and inspection readiness strategies.
Support preparation of documentation required for regulatory agency inspections and internal audits.
Support or lead continuous process improvement and contribute to refinement of clinical operations SOPs (including authoring of SOPs), tools, and best practices.
Directly oversee Clinical Trial Managers and/or Clinical Research Associates, providing coaching and performance feedback and supporting development.