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

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

At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture – one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion – because our differences shape how we hire, collaborate, and innovate. Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific – it's deeply personal, grounded in the meaningful connections we have built.

Agios Pharmaceuticals is searching for a dynamic CTA/Sr. CTA 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 CTA/Sr. 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/Sr. 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.

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, including but not limited to issue tracking, protocol deviation review, and study status reporting, to help ensure quality, timeliness, and achievement of study goals.

Serve as a point of contact for CROs, vendors, investigators, and clinical site staff to support study deliverables, effective communication, and strong working relationships.

Coordinate study and project meetings, including schedules, agendas, minutes, and action items, and support process improvement, training, inspection readiness activities, and mentoring opportunities, as appropriate.

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

Support or Lead Trial Master File (TMF) activities, including document submission, quality review, collection of trial documents, and coordination with CRO partners to help maintain TMF completeness and inspection readiness.

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, as appropriate

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

Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you're excited about this role but your previous experience doesn't align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening!

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.

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 and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.

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.