Clinical Research Manager
CurrentMain tasks:- Planning and overseing the budget execution for clinical trials- Development and implementation of trial management documents such as study protocol, monitoring plans, submission documents, statistical analysis plan, recruitment plan, risk mitigation plan, among others- Support in the training of the study team, including both internal and external stakeholders such as Clinical Operations Manager, Clinical Research Associates or Clinical Study Team, among others- Establishment and monitoring of key trial milestones- Driving trial activities from start-up phase until final CSR, as well as all their related milestones- Revision of study reports, including but not limited to monitoring reports, CSR or periodic study reports - Implementation of risk mitigation plan, corrective and preventative action plans and root-cause analysis- Liaises with the internal and external stakeholders and cross-functional teams for milestone achievements- Provision of reports and metrics on all clinical activities- Conduction of onsite visits either due to co-monitoring puroposes or boosting visits- Responsible for eTMF completness and inspection ready- Oversight of third-party vendors, including CRO
