Local Trial Manager, Sponsor Dedicated → Responsable local(e) des essais cliniques, dédié(e) au promoteur
Core
Local management of clinical trials within assigned countries, ensuring studies are conducted in accordance with protocol requirements, applicable regulations, and ICH-GCP guidelines.
Role type
Senior clinical trial operations manager (country-level)
Builds
Operational study delivery from startup through closeout for pharmaceutical and biotech clients
Domain
Clinical research / Life sciences
Required skills
Clinical trial management, site identification and selection, regulatory compliance (ICH-GCP), patient recruitment strategies, risk mitigation, vendor management, budget management, audit readiness, safety reporting
Preferred skills
Multicountry trial experience, CTMS/eTMF proficiency, process improvement, stakeholder relationship building
Technologies
CTMS, eTMF, Microsoft Office
Responsibilities
Lead country-level execution of assigned clinical trials, support site identification and activation, monitor study progress and mitigate operational risks, ensure compliance with regulatory requirements and GCP guidelines, oversee site readiness and performance, partner on recruitment and retention strategies, coordinate local regulatory submissions, maintain study documentation, support audit and inspection readiness, report safety-related information and protocol deviations
Seniority
Senior, hands-on IC