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Senior Clinical Study ManagerPosted by: Astellas
Posted date: Mar-17-2016
Location: Northbrook, IL
The scope of this position is Phase 1 through 4 global clinical studies. This position may directly manage or oversee management of multiple studies.
Essential Job Responsibilities:
1. Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
2. Manage and lead cross-functional study teams, including vendors
3. Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
4. Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
5. Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data
6. Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
7. Lead feasibility assessment and selection of countries and sites for study conduct
8. Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
9. Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
10. Participate in process improvement and quality-related initiatives associated with study execution and deliverables; participate in establishment of best-in-class processes and standards for study conduct
11. Provide oversight and direction to study team members for study deliverables; may provide direction to Clinical Study Managers, Associate Clinical Study Managers and Clinical Trial Associates for assigned studies
* BA/BS degree with at least seven years multi-country clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 5 years clinical trial experience
* Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
* Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
* Requires proven project management skills and study leadership ability.
* Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
* Fluent in English.
Moderate (25%) travel required.