Local Study Associate Director
On-site · Karnataka, India
Job Summary
Lead country-level delivery of assigned clinical studies, guiding Local Study Teams (CRAs/CSAs and contributors) to meet timelines, budgets, and high-quality data in alignment with Global Study Teams. Oversee feasibility assessments, site strategy, EC/IRB submissions, regulatory affairs coordination, and payment accuracy, ensuring adherence to ICH-GCP and local regulations. Responsibilities include end-to-end country study delivery, risk management, site qualification visits, overseeing monitoring from activation to closeout, training and coaching team members, and maintaining inspection readiness of eTMF. Strong leadership, collaboration with site staff and global stakeholders, and ability to manage cross-functional activities across a matrix organization are essential. Desirable skills include multi-therapy experience, investigator engagement, national investigator meetings, country-level budgeting, and proficiency with CTMS/eTMF and local platforms. This role is based in India (Karnataka) with an in-country, on-site focus.
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