Associate Etmf Jobs (NOW HIRING)

Associate Manager/Manager, Clinical Systems (CTMS, eTMF), CDOC

Who we are:

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. To learn more, visit www.agios.com and follow Agios on LinkedIn and X.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Associate Manager/Manager, Clinical Systems (CTMS, eTMF) to join our growing team, is accountable for day-to-day clinical business systems operations, ensuring systems are designed and implemented with appropriate controls and are successfully adopted. In partnership with the AD, Clinical Systems and Sr. Manager, Clinical Systems, the Associate Manager/Manager, Clinical Systems serves as the Clinical Business Administrator for key clinical trial systems, including CTMS and eTMF.

What you will do:

• Support and/or function as a Clinical Business Administrator for CTMS and eTMF.
• Serve as a CTMS and eTMF Subject Matter Expert (SME), providing end-user support and troubleshooting to diagnose and resolve system issues.
• Partner with the business to understand use cases and/or system needs, and deliver system changes and configuration updates that support organizational adoption of the CTMS and eTMF platform.
• Alongside the Sr. Manager, Clinical Systems, coordinate and support ongoing computer system validation activities in alignment with product releases and/or configuration updates or enhancements. Collaborate with IT, QA and the 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.
• Identify opportunities to enhance system functionality by evaluating system releases against business requirements, recommending configuration updates for CTMS and eTMF. Partner with impacted functions to assess the need and readiness for implementation.
• 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

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!

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. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
• 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.
  • The current base salary range for this position at the Associate Manager level is expected to be between $94,025 and $141,038 annualized and the current base salary range for this position at the Manager level is expected to be between $110,029 and $165,044 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
• 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.