**Global Clinical Trials Assistant - Home Based role**Location: México City / Monterrey**Services Overview**:Clinical Trial Assistance services provides global support for the Local Trial Manager (LTM)/Trial Manager (TM) and/or Site Manager (SM) or Bus ops CTL&D.**Deliverables**:- Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, etc.- Complies with relevant training requirements.- Provides the following deliverables: tracks progress of the clinical trial, manages study data, budget, investigational products, mailings and correspondence and other relevant tasks in support of the LTM/TM and SM.- Maintains trial, country and site level protocol information in trial management systems, including but not limited to relevant systems to ensure appropriate safety update distribution.- Ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site(s) within required timeframes.- Collects and files all documents throughout the trial and post-trial (GCO) or protocol specific training related documents (CTL&D).
Uses appropriate systems to ensure file completeness at designated study milestones.
Coordinates archiving of paper study relevant documents/files.- Ensures audit and inspection readiness.- Provide process improvement suggestions if applicable.
**Requirements**:- Degree in Life Sciences, Nursing or related scientific field (or equivalent experience).- Relevant clinical trial experience with associated skill sets- Proficient in English language (spoken and written).- Strong knowledge of MS Office- Strong interpersonal and negotiating skills- Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment- Experience in Veeva Vault TMF is desirable