Clinical Trial Associate
Amylyx
Cambridge, MA
Job description

Are you looking for a place where your work can have a deeper impact than you ever imagined—and where you can be true to yourself?

At Amylyx, we're bringing together talented people like you who are committed to solving for humanity's most devastating diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer's disease, and others—all in a uniquely supportive, respectful environment that rewards innovative thinking, committed teamwork, and boundless curiosity.

Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences—in all the best ways.

We provide a competitive employee benefits package including stock options and RSUs; flexible work options including hybrid and remote; discretionary time-off; comprehensive healthcare, including dental and vision coverage; and retirement savings benefits.

POSITION SUMMARY

The Clinical Trial Associate will support the Global Clinical Operations (GCO) team in study execution and may act as the central contact for project communication and documentation. Reporting to the Head, Global Clinical Operations you will be responsible for supporting the critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols and under the general supervision of the Clinical Trial Manager, Lead or Head of GCO. In this role you will collaborate with GCO members, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.

RESPONSIBILITIES

  • Coordinate and attend study team meetings; take, distribute, and file meeting minutes.
  • Maintain and generate applicable study trackers (for example: patient enrollment and IRB approvals).
  • Manage deliverables, navigate changing priorities, and communicate any changes.
  • Overall management of the Trial Master Files (internal and CROs) including managing set-up, maintenance, and periodic QC.
  • Manage the GCO internal document filings and tracking.
  • Coordinate tracking of clinical supply shipments, reviews and/or approve study documentation including essential document packets, study plans, informed consent forms, etc.
  • Professionally interact and communicate with internal departments (Legal, Regulatory, Safety, etc.), CROs, and external vendors.
  • Maintain knowledge and act as team super-user or subject matter expert for related systems and processes; provide presentations, training, and support to CTA team as needed; provide updates to applicable CTA resources as needed.

REQUIREMENTS

  • Bachelor's degree (or equivalent) in a relevant scientific field preferred.
  • 2 - 3 years of experience working on clinical studies in academic, pharmaceutical or CRO setting.
  • Experience with essential documentation for Trial Master Files.
  • Knowledge of drug development, clinical operation processes, medical terminology, and procedures according to FDA GCP/ICH regulatory guidelines.
  • Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.
  • Excellent interpersonal and communication skills with ability to work collaboratively across functional teams.
  • Strong organizational and time management skills, and strong attention to detail.
  • Knowledge in global regulatory and compliance requirements for clinical research.

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx's current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Watch this inspirational video of how our Co-founders worked with Patheon and Thermo Fisher in the early days of starting Amylyx.

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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

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