Job Title: Sr. Clinical Operations Consultant (Dir/Sr. Director level)

Work Location: Montgomery County, Maryland

Summary:
This role will serve as a hands-on clinical execution leader for a newly IND-cleared program, with an immediate emphasis on rapid study start-up, vendor oversight, and selecting / activating high-performing investigational sites. You will operate as a key extension of the internal team, ensuring external partners deliver with urgency, quality, and accountability.

Responsibilities:

• Own day-to-day oversight of external clinical trial partners, including CROs, investigational sites, central labs, research consultants, and other supporting vendors.
• Drive immediate site strategy execution, including site identification, feasibility inputs, and site selection support to keep timelines aggressive and realistic.
• Coordinate and oversee contracted vendor deliverables, ensuring performance aligns with protocol timelines, quality standards, and budget expectations.
• Partner closely with Quality Assurance to prepare for, support, and participate in vendor and site audits, ensuring inspection readiness from the start.
• Track and communicate program execution status, including study progress, operational metrics, budget updates, key accomplishments, and risks or mitigation plans.
• Identify issues early (vendor performance, site responsiveness, operational gaps) and proactively escalate with solutions to protect enrollment and milestone timelines.

Qualifications:

• 12+ years of clinical research experience, including direct on-site monitoring experience.
• 8–10+ years leading clinical trial operations as a Clinical Project Manager (or equivalent) within biotech/pharma or a CRO environment.
• Strong working knowledge of vendor management, site start-up strategy, and fast-moving clinical execution in early-stage programs.

Published Category: Clinical Operations & Development