Clinical Trial Associate/Sr. Clinical Trial Associate, Clinical Operations

About the role

Agios Pharmaceuticals is seeking a Clinical Trial Associate or Senior Clinical Trial Associate to join our growing Clinical Operations team. The ideal candidate will care about this important work and be driven to connect to our mission of helping rare disease communities.

Responsibilities

• Partner with Clinical Operations Trial Managers and cross-functional teams to support the planning, coordination, and day-to-day execution of clinical trials across the study lifecycle.
• Support the development and production of timelines, budgets, various study plans, and throughout the duration of the assigned clinical trial(s).
• Provide support during clinical study planning, including issue tracking, protocol deviation review, and study status reporting.
• Coordinate study and project meetings, including schedules, agendas, minutes, and action items.
• Assist in the preparation, review, and maintenance of study documentation, including training records, regulatory packets, informed consent forms, site materials, etc.
• Manage country specific insurance certificate requirements.
• Contribute to safety reporting compliance, data review support, and identification or escalation of study risks and operational issues, as needed.
• Coordinate and track clinical supplies, equipment, and study-specific laboratory samples to support ongoing trial activities.

Requirements

• Bachelor's degree in a scientific or healthcare field (preferred)
• 2+ years' experience in relevant field (e.g. clinical site, CRO, Sponsor or clinical trial vendor)
• Strong skills in collaboration, communication, organization, attention to detail, and multi-tasking
• Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency
• Understanding of ICH-GCP guidelines, clinical trial monitoring, and/or regulatory compliance (preferred)
• Comfortable working in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands

Qualifications

• Must be comfortable working in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands
• Must be able to work in a team-oriented environment
• Must be able to communicate effectively with cross-functional teams
• Must be able to manage multiple projects simultaneously
• Must be able to prioritize tasks and meet deadlines

Skills

• Strong organizational and time management skills
• Excellent written and verbal communication skills
• Ability to work independently and as part of a team
• Proficiency in Microsoft Office Suite
• Knowledge of ICH-GCP guidelines, clinical trial monitoring, and/or regulatory compliance (preferred)

Benefits

• Premium benefits package
• Competitive and equitable performance-based compensation
• Psychological safety
• Commitment to diversity
• Commitment to community