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17 часов назад

Senior Clinical Trial Manager (AI Drug Discovery)

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR
Senior Clinical Trial Manager (AI Drug Discovery): Leading cross-functional oncology and rare disease clinical trials through start-up, conduct, and closeout with an accent on GCP/ICH compliance, vendor oversight, and clinical document readiness. Focus on managing outsourced trial operations, coordinating data cleaning and safety activities, and evaluating AI solutions to improve clinical operations.

Location: Cambridge, Massachusetts, United States; hybrid work with office attendance required three days per week

Company

hirify.global applies frontier AI and machine learning to drug discovery, designing predictive and generative models to accelerate the development of innovative medicines.

What you will do

  • Lead cross-functional clinical trial activities from study start-up through conduct, maintenance, and closeout in accordance with ICH/GCP and corporate standards.
  • Manage vendor and site change orders, re-scoping, invoices, accruals, performance metrics, and key operational indicators.
  • Drive the preparation and review of clinical documents, trial plans, training materials, manuals, and submission-readiness deliverables.
  • Coordinate data management, data cleaning, data snapshots, data deliveries, and review of study-related data materials.
  • Coordinate investigator, clinical study team, vendor, safety review committee, and data safety monitoring board meetings.
  • Support eTMF maintenance, audits, SOP activities, and quality oversight to ensure audit-ready trial records.

Requirements

  • Bachelor’s degree in a related field and at least six years of experience in the biotechnology and/or pharmaceutical industries.
  • At least three years of experience managing oncology or rare disease trials.
  • Thorough knowledge of GCP/ICH guidelines and cross-functional clinical processes.
  • Strong interpersonal, written, verbal communication, problem-solving, planning, and project management skills.
  • Strong experience with outsourced clinical models and vendor budget management.
  • Ability and willingness to travel up to 30% and work from the Cambridge office three days per week.

Nice to have

  • Prior CRA experience or willingness to co-monitor when needed.
  • Prior site, coordinator, or related clinical trial experience.

Culture & Benefits

  • Hybrid collaboration model designed to support knowledge sharing and strong working relationships.
  • Culture centered on thoughtfulness, curiosity, creativity, care, initiative, integrity, determination, and collaboration.
  • Learning is shared and employees are supported in an inclusive environment that values diverse experiences and perspectives.

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