Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company. Astellas is announcing a Senior Clinical Study Manager opportunity in Westborough, MA.
Purpose & Scope:
Plan, initiate and execute assigned clinical studies with operational excellence
· Be accountable for effective management of budgets, timelines and resources for assigned clinical studies and implementation of appropriate standards and processes to ensure clinical study quality
· Be responsible for effective training and management of interactions with study team, study sites and vendors for assigned clinical studies
· Participate in best-in-class initiatives to improve study execution standards and processes and to ensure quality of study deliverables
The scope of this position is Phase 1 through 4 APGD-sponsored clinical studies. This position may directly manage or oversee management of multiple studies
Essential Job Responsibilities:
- 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
- Manage and lead cross-functional study teams, including vendors
- 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
- 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
- Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data
- Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
- Lead feasibility assessment and selection of countries and sites for study conduct
- 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
- 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
- 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
- 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
Responsible for the preparation and management of budgets, timelines and resources for assigned clinical studies. Responsible for study budgets up to $100M.
Reports to the Senior Manager, Clinical Study Management or above. This position has no direct reports but may provide oversight and direction to study team members for study deliverables and may provide supervision to Clinical Study Managers, Associate Clinical Study Managers and Clinical Trial Associates.
- 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.