*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