Associate Manager, Clinical Systems

Associate Manager, Clinical Systems 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 rare disease - 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 Associate Manager, Clinical Systems to join our growing Clinical Systems 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 Associate Manager, Clinical Systems will support and/or function as the business system administrator for CTMS and eTMF, in partnership with the business system owner.

This role will focus on driving successful configuration, customization, and validation of clinical trial systems to meet protocol requirements and regulatory standards, with strong partnerships with stakeholders across the R&D organization. What you will do: Support and/or function as the business system administrator for CTMS and eTMF.

Contribute to system change and configuration updates, in partnership with the business, to support organizational adoption of a new CTMS and eTMF platform. Coordinate and support computer system validation activities in alignment with product releases and/or configuration updates or enhancements. Partners with IT, QA and Business System Owner to implement system change management.

Contribute to standard operating procedures, work-instructions, and training material creation and/or revision, in partnership with multiple stakeholders across the R&D organization. May assist in management of additional clinical technologies, as assigned, that are leveraged in clinical trials, developing system vendor strategy, partner selection, system standards and internal processes to ensure compliant systems development and operations. What you bring:

Bachelor's degree and 3+ years relevant work experience with CTMS and eTMF implementation and support Experience with computer system validation of GxP systems strongly preferred. An ideal candidate will have direct experience with Veeva CTMS and eTMF. Strong project management skills, and ability to effectively support system design discussions and collaborate with various business functions.

High attention to detail including proven ability to manage multiple, competing priorities. Demonstrated ability to influence change. Excellent written and oral communication skills Flexibility and cross functional collaboration 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.