mscr sase boyo

* Provide leadership, coordination, and management of the PPD-customer joint project team through start-up, conduct, tracking, quality, and regulatory compliance management and close-out activities. * Manage clinical resources according to projections of ongoing clinical activities to ensure resources are aligned to maintain forward movement of clinical deliverables. * Manage clinical budget; escalate out-of-scope activities to project management, forecast unit grid and update unit actuals. * Prepare monitoring plan, as well as responsible for the implementation and training of standardized clinical monitoring processes within the study team.

* Oversee a high-performing staff of 30 across different projects and the daily operations of the Company local office. Ensure individual and work group/team tasks are completed according to country specific and government regulations. * Manage Global Clinical Study supply coordination, manufacturing, ordering, and distribution. * Build effective and efficient high-performing operations teams. * Responsible and contribute to the development and management of study timelines, resources, budget, risks and quality plans. * Oversee and provide directions on packaging, labeling, sourcing, manufacturing, distribution, design and inventory control of study products.

* Perform activities for the planning and developing of clinical trials. Compile quality documentation including reports on quality processes, procedures and assessment of standards. * Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices.

* Data collection and analysis using appropriate information systems. * Development and formulation of project reports, studies and technical documentation. * Managed and monitored data, reconciled data discrepancies for quality assurance of research studies.

* Pre-study, initiation, routine monitoring and close out visits at study sites to ensure clinical study is being conducted in compliance with protocol, stated SOPs and ICH GCP guidelines. * Update clinical trial management systems with timelines, and pertinent study information. * Collection/review of study and regulatory documents (i.e. Case Report Forms, Financial Disclosure Forms, etc).

* Review and catalog incoming adverse events to improve quality standards of products. * Generate reports on adverse events to ensure quality improvement of company products.

* Maintain and enter clinical data using Clintrace; mail and track Investigational Product and supplies to study sites. * Maintain and ensure that clinical trial documents (i.e. Financial Disclosure Forms, CVs, Lab Certification, etc) are received from clinical sites in a timely manner.