Associate Director, Clinical Operations Study Lead
Core
Lead operational execution of Phase I-III global clinical trials for neuromuscular diseases, managing CROs, vendors, and study teams to ensure compliance, timeline, and budget adherence.
Role type
Senior IC clinical operations study lead
Builds
Clinical trials for Duchenne muscular dystrophy (DMD), myotonic dystrophy type 1 (DM1), and other neuromuscular conditions
Domain
Biopharma / Clinical Operations / Neuromuscular Diseases
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global clinical trial management (Phase I-III), CRO oversight, budget forecasting, risk assessment, team leadership, regulatory compliance (ICH GCP), site engagement
Preferred skills
Neuromuscular or muscle disease experience, rare disease/pediatric trial experience, prior site or monitoring experience
Technologies
Clinical trial management systems (CTMS), electronic data capture (EDC), TMF management tools
Responsibilities
Manage operational aspects from start-up to close-out of studies; Develop study-level operational strategies; Manage invoice and budget tracking; Support selection and oversight of CROs; Lead cross-functional teams and study teams; Participate in site engagement programs; Coordinate investigator meetings; Conduct proactive data monitoring; Create risk assessments and mitigation plans; Review clinical documents and ensure TMF inspection readiness; Prepare reports for senior management; Provide coaching and mentoring to indirect reports.
Seniority
Senior, hands-on IC with team leadership
