Senior Manager, Clinical Data Management - Remote

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. 

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Senior Manager, Clinical Data Management, to join our growing Clinical Data Operations and Compliance 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 Senior Manager, Clinical Data Management will be responsible for executing data deliverables for all phases of clinical trials and programs as part of the research and development group. This role will proactively participate within cross functional teams of internal clinical colleagues as well as external contract research organizations and other data vendors, driving end-to-end data quality and integrity from source through to submission. The Sr. Manager of Clinical Data Management will also contribute to the development of departmental documents and procedures.

What you will do:

• Function as internal Study Data Manager, overseeing all data management activities performed by CROs including generation and review of metric status and patient tracking reports; ensuring major DM deliverables and milestones are met
• Assists in review of vendor proposals, budgets, scopes of work; Provides input to protocols, and other clinical study documents during development
• Reviews and manages key documents such as data management plans, guidelines for CRF completion, data review, SAE reconciliation, Vendor Oversight, TMF plans, and data audits.
• Following CDISC conventions, oversees or performs eCRF design and annotation, database design specifications; Develop or oversee CRO generation of data edit check specifications (DVS); Participate in user acceptance testing (UAT) of the clinical database, including edit check testing
• Create Agios specifications for internal study team data review plans, with input from study team
• Contributes to development of the Protocol Deviation Specifications
• Leads internal study team in critical data definition
• Leads internal study team in data review; Perform data review for quality issues and general data trends; generate queries as necessary.
• Defines/oversees data transfer specifications for external data sources (labs, ECGs, PK) and transfer of data; reconcile or oversee CRO lab reconciliation with clinical database
• Work with SAS and/or clinical systems programming to produce in-process data reports and data visualization tools to facilitate decision making on clinical trials (e.g., safety reviews). Provide input on standard tools and reports.
• Study DM liaison with cross-functional team members and external vendors to ensure completion of all timelines and study-related tasks; Ability to work independently as well as within a cross-functional team environment
• May give Data Management presentations and/or training at Investigator Meetings or other meetings, as needed
• Participate in development and implementation of departmental initiatives. Reviews and provides input to improve data management SOPs and guidelines
• Contribute to content development and/or testing of department standards
• May function as a resource or mentor for more junior colleagues or oversee contract staff.

What you bring:

• Bachelors Degree with a minimum of 5+ years experience
• Strong understanding of end-to-end Clinical Data Management in a biotech or pharma environment
• Experience working with DM vendors and CROs highly desirable
• Familiarity with Medidata RAVE and/or other clinical data management software preferred
• Experience executing UAT scripts for testing of electronic data capture systems including eCOA (Electronic Clinical outcome assessment) systems
• Solid working knowledge of MS Outlook, MS Word, MS Excel, MS PowerPoint
• Knowledge of GCP and other regulations
• Must have excellent oral and written communication / presentation / negotiation skills
• Ability to manage multiple (changing) priorities under tight timelines
• Detail oriented, able to identify issues and consistently collaborate to solve problems in a timely manner
• Internal/external customer management, influence of peers, team effectiveness and enhancement, timeline management, proactive problem-solving ability, ability to develop trust, shared goals and values. 
• Collaboration, with negotiation skills, conceptual thinking, systems process thinking, accountability to deliverables milestones, conflict resolution (internal and external) 

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 employees 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 is expected to be between $131,035 and $196,553 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.