Astellas Pharma Clinical Study Manager (In-house/Onsite) in Marlborough, Massachusetts
The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
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.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both hESC and induced pluripotent stem cells -- and other cell therapy research programs. AIRM is headquartered in Marlborough, Massachusetts.
Purpose & Scope:
NOTE: THIS IS NOT A HOME-BASED or REMOTE POSITION. THIS IS AN IN-HOUSE/ON-SITE/SPONSOR SIDE CLINICAL STUDY MANAGER POSITION IN MARLBOROUGH, MA 01752.
The Clinical Study Manager will:
- 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
The scope of this position is Phase I through 4 AIRM-sponsored clinical 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
- Support the study team with timeline and financial management to include updating enrollment projections, changes in scope and or budget information
- 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
- Track and review study milestones, tasks and timelines
- 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 sites for study conduct
- Provide oversight and review of monitoring visit reports ensuring the team meets required timelines for review and submission
- 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
- Provide oversight and direction to study team members for study deliverables and provide direction to Clinical Research Associates (CRAs) and Clinical Trial Associates (CTAs) for assigned studies; this position may have direct reports
- Provides leadership in identifying operational risks and developing mitigation and contingency plans
- Responsible for the preparation and management of budgets, timelines and resources for assigned clinical studies
- Responsible for study budgets up to $100M
- Travel Required: up to 25%
- BA/BS degree with a minimum of 5 years multi-country clinical trial experience or advanced degree (MS/PhD/PharmD) with a minimum of 3 years clinical trial experience
- Must have strong knowledge of ICH/GCP guidelines
- 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, verbal, presentation, administrative and computer skills
- Fluent in English (oral and written)
- Moderate (25%) travel required
- Ophthalmology experience
- Cell-based products/biologics clinical trial experience
The statements above are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Clinical Science