Note: The job is a remote job and is open to candidates in USA. Agios Pharmaceuticals is a company dedicated to transforming rare diseases through an inclusive and collaborative culture. They are seeking an Associate Manager/Manager for Clinical Data Systems (CTMS, eTMF) to oversee day-to-day operations, ensuring effective implementation and support of clinical trial systems.

Responsibilities

• 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

Skills

• Bachelor's degree and 3+ years relevant work experience with CTMS and eTMF implementation and support
• 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
• Experience with computer system validation of GxP systems strongly preferred
• An ideal candidate will have direct experience with Veeva CTMS and eTMF

Benefits

• 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.
• 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.
• 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.
• 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.

Company Overview

Company H1B Sponsorship