Clinical Trial Manager, Clinical Operations
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 genetically defined 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. In addition to its clinical pipeline, Agios has multiple investigational therapies in preclinical development and an industry-leading research team with unmatched expertise in cellular metabolism and genetics.
The impact you will make:
Agios Pharmaceuticals is searching for a dynamic Clinical Trial Manager to join our growing Clinical Operations 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 Clinical Trial Manager will be responsible for leading the planning, implementation and execution of clinical study protocols, operational plans and study timelines, in alignment with study/program goals and Agios’ strategic objectives. Managing all aspects of study progress (from protocol development and planning to study close-out, including supporting the development of clinical study reports), the CTM assures adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMA, GCP, and ICH guidelines. This role is responsible for collaborative and effective management of cross-functional study team activities, as well as communication with and management of multiple external vendors and stakeholders (e.g., CROs, central labs, IRBs/ECs, and other external partners). S/he proactively identifies, manages and communicates risks to key stakeholders and is also in communication and closely integrated with clinical trial sites, promoting relationship development with team members, stakeholders, Investigators and site staff.
What you will do:
- Leads the activities of the Clinical Trial Working Group, a cross-company and cross functional team, as it relates to study-level strategy, timelines, goals, and quality
- Acts as ad hoc member of the Development Sub-Team to collaborate in the program level development of clinical strategies, goal setting, and establishment of timelines
- Evaluates, selects, and ensures appropriate oversight of Contract Research Organizations (CROs) and other external vendors. Builds solid relationships with key counterparts at CRO(s) and other external vendors
- Communicates with clinical trial sites as appropriate to ensure optimal Sponsor-Site relationships
- Communicates trial status within and outside the study team to ensure cross-functional alignment of expectations, priorities, and deliverables
- Provides input to the development of study-level budget(s) and demonstrates accountability for the management of assigned clinical study budget(s) by:
- Tracking vendor performance against scopes of work, contracts, and invoices to ensure consistency between work performed and contractual agreement(s)
- Facilitating review of study-level scopes of work, invoices, change request forms, and change orders to ensure consistency with study progress and/or evolving study needs
- Participates in partnership (e.g., Celgene) meetings and/or shares study information with partner(s), as appropriate
- Anticipates, recognizes, and manages issues exhibits the ability to recognize the need to seek assistance from or inform Senior Management of specific risks/issues; understands when decision making can occur at the study team level versus when there is a need for escalation to the program level or to Senior Management
- Analyzes clinical study and investigative site risks and implements corrective actions, where required
- Drives quality-by-design efforts to proactively identify and manage risks to trial quality and ensure Agios inspection readiness at all times Study Management and Oversight
- Drives site start-up, subject enrollment, clinical monitoring activities, clinical site compliance and data metrics from CROs, central labs, and other external vendors
- Leads development and execution of operational activities outlined in various study plans, SOPs, study procedures, etc.
- Coordinates the development and distribution of critical study documents, including ICFs, operational documents, study reference documents, study newsletters, site materials, and other study related documents; supports the development of clinical study protocols, clinical study reports and other documents as needed
- Partners with Global Supply Chain (Technical Operations) team to provide oversight of the applicable study drug(s), including supply projections, distribution, labeling and destruction
- Tracks clinical study metrics and reports to management on study(ies) run by Agios partners (e.g., Celgene), as applicable
- Plans, facilitates, and monitors training at investigator meeting(s), kick-off meeting(s), and various CRO (or other vendor) meeting(s)
- Performs quality assurance checks (e.g., reviewing protocols for operational effectiveness, monitoring trip reports for potential gaps in site/CRA training, conducting co-monitoring visits at clinical sites, reviewing data listings at interim analysis milestones)
- Coordinates IDMCs, when applicable, including collecting confidentiality agreements, contracts, and conflict of interest forms from IDMC members, reviewing IDMC Charter, planning and scheduling meeting(s)
- Supports and collaborates with GCP QA during site selection and site/study audit activities
- Leads Clinical Operations preparation of inspection readiness activities for FDA and other applicable regulatory body audits and/or meetings
- Provides guidance and shared learning within and across teams
- Mentors more junior Clinical Operations staff member(s) Participates in internal and external training programs to ensure skills are learned and maintained
- Champions operational best practices and seek opportunities for innovation and efficiencies within the Clinical Operations group
- Participates in internal Agios SOP, WI, and/or template development and review
- Performs administrative functions and additional duties as assigned and appropriate
What you bring:
- Bachelor’s degree with a life science or healthcare focus or nursing degree required
- 5+ years’ direct clinical trial management experience (sponsor experience required)
- Experience in hematology or rare disease/orphan indications preferred
- A detailed understanding of overall strategic direction, interrelationships and business needs
- Management of CROs with multiple vendors and complex protocols
- Proven experience in the oversight of the operational aspects of all stages of clinical studies, preferably in a global environment
- Exhibits the ability to recognize the need to seek assistance from or inform Senior Management of specific risks/issues; understands when decision making can occur at the study team level versus when there is a need for escalation to the program level or to Senior Management
- Knowledge of ICH GCP and knowledge of Medical Terminology strongly preferred
- Ability to organize and manage multiple priorities required
- Excellent oral and written communication skills required
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._
Agios requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC) on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief, observance, or practice that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.
Job Type: Full-time