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2 дня назад

Senior Clinical Operations Contractor (Biotech)

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

Текст:
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TL;DR
Senior Clinical Operations Contractor (Biotech): Leading the planning, execution, oversight, and closeout of clinical trials across DMD and DM1 genetic medicine programs with an accent on CRO and vendor oversight, trial compliance, and clinical data integrity. Focus on coordinating cross-functional trial teams, resolving conduct issues, overseeing monitoring from site qualification through closure, and supporting database lock.

Location: US-based remote position with minimum monthly or quarterly travel to the headquarters in Boston, Massachusetts. Preference is given to candidates based in New England.

Company

hirify.global is a clinical-stage biopharmaceutical company developing genetic medicines for neuromuscular and inherited retinal diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1.

What you will do

  • Lead the day-to-day planning, setup, execution, and closeout of assigned clinical trials.
  • Evaluate and oversee CROs and other vendors, including country and site selection.
  • Support protocols, study plans, manuals, informed consent documents, eCRFs, investigator brochures, and clinical study reports.
  • Lead cross-functional trial teams and coordinate internal stakeholders and external vendors.
  • Monitor trial progress, enrollment, eligibility, protocol deviations, adverse-event reporting, and conduct-related issues.
  • Oversee clinical monitoring, data review, reconciliation, and database lock activities.

Requirements

  • BA/BS degree and 7+ years of experience supporting and independently managing clinical trial activities.
  • Strong knowledge of ICH/GCP and regulatory requirements, with experience with EU-CTR preferred.
  • Strong experience with drug development, trial design, trial planning, clinical trial management, CRO oversight, and vendor management.
  • Excellent verbal and written communication skills.
  • Demonstrated ability to work effectively across functions.
  • US-based remote work and minimum monthly or quarterly travel to Boston are required.

Culture & Benefits

  • Long-term contract position with an expected workload of 30–40 hours per week.
  • Values include humanity, tenacity, creativity, collaboration, and curiosity.
  • Work in a fast-paced clinical-stage biopharmaceutical environment focused on rare-disease therapies.

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