Clinical Trial Assistance
hace 6 meses
**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
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