Manager, Data Management Standards – Remote – Agios Pharmaceuticals

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 diseases – 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 Manager, Data Management Standards 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 Manager, Data Management Standards is responsible for the development, oversight, and management of the Agios clinical data collection and clinical data review standards libraries.  He/She/They will define and maintain the processes related to the management and use of the standards and will ensure key stakeholders are trained in their use. He/She/They will interact with team members from many functions to drive the development and adoption of the data standards within Agios and our partner CROs.  The Manager, Data Management Standards will drive compliance by leading the Standards Governance Team and by developing and utilizing metrics to help measure adherence and efficiency.  He/She/They will utilize their technical skill set and knowledge of industry standards, data collection system development, and data transfer standards to ensure continuous improvement to the standards libraries and adherence to CDISC controlled terminology.

What you will do:

• Responsible for the development and maintenance of the Data Management data collection standards including CRFs, validation rules, CRF completion guidelines, data transfer specifications, standard integrations (e.g. with IWRS), and standard data cleaning listings/reports libraries
• Leads Cross Functional Data Standards Team, driving development of new and updated collection standards by developing strong and productive working relationships with key stakeholders throughout Clinical Systems, Biometrics, Clinical Operations, DMPK, Translational Medicine, Safety, and Clinical Development
• Leads Cross Functional Data Standards Governance Team responsible for ensuring timely review and adjudication of standards deviation requests
• Defines and manages compliance metrics and leverages them to improve global libraries and processes as needed
• Defines and maintains business processes related to the definition, use, maintenance and sharing of clinical data standards.  Trains internal and CRO stakeholders in use of standards in study builds
• Supports or develops eCRF design and annotation, database design specifications; data edit check specifications (DVS) for standard eCRFs; Participates in user acceptance testing (UAT) of the eCRF global library, including standards edit check testing.
• Supports or develops Data Cleaning Listing specifications; Participates in user acceptance testing (UAT) of the Standards Data Cleaning Listings/Reports.
• Develops and maintains training documentation for staff performing data review using standard data review tools and processes
• Develops and maintains library of standard Data Transfer Agreements (DTA) with key vendors
• May support other process definition projects or perform ad hoc data management task as necessary
• Encouraged to participate in industry forums and conferences with a focus on data collection standards

What you bring:

• BS/BA in Life Sciences or equivalent preferred
• At least 5 years of Clinical Data Management experience and a successful track record of leading through influence, working across complex organizational matrices.  Prior standards management experience preferred.
• Good understanding of the drug development process with proven expertise in clinical trial execution and data acquisition.
• Strong knowledge of industry clinical data standards and processes (e.g., CDISC: CDASH/SDTM) and well versed in industry best practice documentation from regulatory authorities.
• Strong technical knowledge of industry leading EDC systems (e.g., Medidata Rave, Veeva, etc.) and well versed in industry trends and emerging technologies supporting end to end solutions for data collection through submission (e.g., Metadata Data Repositories, Data Warehouse, Clinical Data Repository).
• Experience with process development, management, and training
• Strong knowledge of GCP/ICH guidelines.
• Influential leadership and communication capabilities with a proven ability to engage and manage a diverse cross functional team.
• Ability to work independently or as a team member with equal effectiveness
• Ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

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.