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Atrium Therapeutics
Atrium Therapeutics
11 – 50 Zaposleni
BiotehnologijaFarmacevtski izdelki
Atrium Therapeutics is a clinical-stage biotechnology company developing RNA medicines for genetic and rare heart diseases. Its cardiac delivery platform builds on antibody-oligonucleotide conjugate technology to direct oligonucleotide therapies to heart muscle. The pipeline includes ATR-1072 for PRKAG2 syndrome and ATR-1086 for PLN cardiomyopathy, alongside research-stage programs for other rare cardiomyopathies. Atrium plans to file an investigational new drug application for ATR-1072 in the second half of 2026. The company’s work brings together RNA therapeutics and precision cardiology, with its research and development programs focused on conditions affecting the heart.
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Delovna mesta v podjetju

Senior Clinical Trial Manager, Remote (California)

Lead global clinical operations for Atrium Therapeutics’ RNA therapies targeting cardiomyopathies. Oversee CROs, vendors, budgets, timelines, compliance, and trial delivery.

USZdružene države AmerikeCAKalifornija
171.000 $ – 189.000 $ / leto
Na daljavoPolni delovni časSeniorZahtevani Jezik: angleščinaKlinične raziskave
Google Cloud Platform

Opis

  • Own clinical study operations, including CRO and vendor oversight, project plans, budgets, and resource allocation.
  • Develop study operational plans and contribute to functional plans and processes.
  • Oversee CROs, vendors, and sites to maintain GCP and regulatory compliance.
  • Represent clinical operations on cross-functional teams.
  • Coordinate study timelines and budgets with the Clinical Operations Lead, internal leaders, and CROs.
  • Manage study vendors and define deliverables and KPIs.
  • Create study-specific training for site staff, CRAs, and vendors, and present at investigator and kick-off meetings.
  • Oversee submissions and approvals with competent authorities and IRB or ethics committees.
  • Design monitoring strategies that support study timelines and quality deliverables.
  • Oversee eTMF structure, planning, and quality.
  • Manage investigator selection, drug supply projections, study start-up, recruitment and retention, data collection, database locks, drug accountability, and closeout.
  • Contribute to trial outlines, protocols, informed consent forms, and clinical study reports.
  • Lead or support project plans, training, system builds, CRF designs, and user acceptance testing.
  • Identify and resolve issues and risks with cross-functional teams and service providers.
  • Work with data management and CRAs to maintain data quality and meet cleaning timelines.
  • Conduct clinical data reviews, including generating queries as needed.
  • Contribute to process improvements, initiatives, and SOPs.
  • Guide and mentor junior team members.
  • Escalate CRA performance and site compliance concerns.
  • May manage direct reports.

Zahteve

  • Bachelor’s degree, preferably in life sciences or an equivalent field.
  • At least 8–10 years of clinical operations experience.
  • Experience managing a CRO and a complex study as a Clinical Trial Manager or in an equivalent role.
  • Global Phase I–III clinical trial experience.
  • Rare disease experience required; cardiovascular experience is a plus.
  • Inspection readiness and inspection experience are advantageous.
  • Strong attention to detail and organizational skills.
  • Excellent oral and written communication, analytical, and project management skills.
  • Ability to build and sustain collaborative relationships with internal and external stakeholders.
  • Ability to manage competing priorities, handle conflict and obstacles, and work in a fast-paced setting.
  • Ability to learn and use technical applications quickly.
  • Experience with Smartsheet, MS Excel, or equivalent tools preferred.
  • Ability to manage budgets and forecasts.
  • Prior auditing experience preferred.
  • Prior experience as a Clinical Research Associate (CRA) preferred.
  • In-depth knowledge of ICH/GCP, regulatory guidelines and directives, drug development, and clinical research processes.
  • Team leadership experience in a cross-functional matrix environment.
  • Availability for approximately 10–15% national and global travel for meetings and conferences.

Ugodnosti

  • Stock options.
  • 401(k) with employer match.
  • Medical coverage.
  • Dental coverage.
  • Vision coverage.
  • Long-term disability coverage.
  • Unlimited time off, including summer and winter breaks.
  • Company-developed learning and development programs.
  • Role-specific training provided by the industry.
  • Education reimbursement program.

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