Clinical Trial Associate, Clinical Operations

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for genetically defined diseases – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Clinical Trial Associate to join our growing Clinical Operations team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Clinical Trial Associate (CTA) will administer, maintain, and coordinate the logistical aspects of clinical trials and participate in a variety of clinical activities to support and facilitate the efficient conduct of Agios’ clinical research programs. The CTA will focus on providing support during clinical study planning, the development and production of timelines, budgets, various study plans, and throughout the duration of the assigned clinical trial(s). They will adhere to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMA, GCP, and ICH guidelines.

What you will do:

• Assist in the coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samples
• Provide oversight of activities related to safety reporting compliance
• Review and maintain study-level training documentation
• Review study-specific essential regulatory document packets prior to site activations
• Post, update, and maintain information on clinicaltrials.gov registry(ies) and other registries as appropriate
• Act as Functional TMF Document Specialist for Clinical Operations, to include submission of documents to and maintenance of the Trial Master File (TMF); review TMF documents as part of the
• Quality Review Process; act as primary liaison with the CRO to collect trial documents and coordinate review of the electronic TMF to ensure inspection readiness at all times
• Manage insurance certificate requirements
• Obtain and disseminate schedules and calendars; prepare and distribute agenda and minutes for project team meetings and client meetings
• Provide agenda, minutes, and action items for a variety of internal Agios meetings

What you bring:

• Bachelor's degree is required (scientific/health care 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
• Must be comfortable working in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands 

Work Location:

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.

What we will give you:

• Deliberate Development. Your professional growth as one of our top priorities.
• Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
• Premium benefits package. We invest in the health, wellbeing and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
• Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.