Clinical Trial Associate
Agios Pharmaceuticals4.3
Remote
Job details
Estimated: $75,000 - $100,000 a year
Full time
Benefits
Health insurance
Job description

Clinical Trial Associate, 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 Associate 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 Associate (CTA) will administer, maintain, and coordinate the logistical aspects of clinical trials and participate in a variety of clinical activities to support and facilitate the efficient conduct of Agios’ clinical research programs. The CTA will focus on providing support during clinical study planning, the development and production of timelines, budgets, various study plans, and throughout the duration of the assigned clinical trial(s). They will adhere to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMA, GCP, and ICH guidelines.
What you will do:

  • Assist in the coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samples
  • Provide oversight of activities related to safety reporting compliance
  • Review and maintain study-level training documentation
  • Review study-specific essential regulatory document packets prior to site activations
  • Post, update, and maintain information on clinicaltrials.gov registry(ies) and other registries as appropriate
  • Act as Functional TMF Document Specialist for Clinical Operations, to include submission of documents to and maintenance of the Trial Master File (TMF); review TMF documents as part of the Quality Review Process; act as primary liaison with the CRO to collect trial documents and coordinate review of the electronic TMF to ensure inspection readiness at all times
  • Manage insurance certificate requirements
  • Obtain and disseminate schedules and calendars; prepare and distribute agenda and minutes for project team meetings and client meetings
  • Provide agenda, minutes, and action items for a variety of internal Agios meetings

What you bring:

  • Bachelor's degree is required (scientific/health care field preferred)
  • 2 years’ experience in relevant field (e.g. clinical site, CRO, Sponsor or clinical trial vendor)
  • Strong skills in collaboration, communication, organization, attention to detail and multi-tasking
  • Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency
  • Understanding of ICH-GCP guidelines, clinical trial monitoring, and/or regulatory compliance preferred
  • Must be comfortable working in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands

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

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Company details

Employee

201 to 500

Revenue

$25M to $100M (USD)

Company Description
Agios Pharmaceuticals is a public American pharmaceutical company focused on developing small-molecule anti-cancer therapeutics targeting cancer cell metabolism via the growth factor pathway. Among the proteins under investigation by the company are IDH1 and IDH2. The company was founded in 2008 (or 2007) by Lewis Cantley, Tak Mak and Craig Thompson. Agios is a Delaware corporation headquartered in Cambridge, Massachusetts.
Company ratings
  • Overall
    4.3
  • Company & Benefits
    4.5 / 5
  • Culture & Values
    4.2 / 5
  • Career Opportunities
    3.9 / 5
  • Work/Life Balance
    3.9 / 5
  • Senior Management
    3.9 / 5
Company reviews
"Nice place before oncology unit sold"
Current EmployeeData Manager
Since the oncology unit was sold, there has been lack of room for people to grow. They did care about people and organized some activities to cheer people up but just in general you won’t like it when the size of the company shrinks.

"Excellent culture and team members. "
Former EmployeeSenior Talent Acquisition Specialist
I love this company. Their culture is awesome! I loved working with everyone, especially our HR /TA team. What a wonderful group of people! I can't say enough good things about the woman I reported to! She was personable, welcoming, helpful, smart, great at her job, fun and wonderful at managing and developing her team members. I will always have fond memories of my time at Agios.
Pros:
Cons:

"Good for R&D but not for G&A"
Current EmployeeManager
Company looks very tech oriented but very outdated in terms of upgrade in the systems and applications in G&A. If you are in G&A function, think twice before joining as you may find yourself manually work to save the marginal budget of a department. G&A workforce is very lean with high turnover.

"Fun place to work"
Former EmployeeSenior Manager
Great place to work, the company is growing, but culture remains the same which is hard for any company to keep....but they are doing it :) Agios has a great crossfuctional learning experience with the ability to wear more then one hat.