4 дня назад
Integrated Study Timeline Manager (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Integrated Study Timeline Manager (Clinical Research): Developing, customizing, and maintaining integrated study timelines for global clinical trials with an accent on cross-functional coordination, critical path management, and timeline quality. Focus on identifying delays and conflicting activities, managing complex Microsoft Project or Planisware schedules, and supporting timeline processes throughout the clinical trial lifecycle.
Location: Remote, Blue Bell, United States
Company
is a healthcare intelligence and clinical research organization supporting pharmaceutical and clinical development programs.
What you will do
- Develop, customize, maintain, and regularly update integrated study timelines for global clinical trials.
- Coordinate timeline discussions and participate in study execution meetings with Global Trial Leads and cross-functional stakeholders.
- Identify critical path items, delays, roadblocks, gaps, duplicate activities, and conflicting event sequences.
- Run timeline status reports, manage SharePoint user access, and prepare kickoff, customization, and handover materials.
- Support Microsoft Project training, open-house sessions, timeline tools, templates, and related process documentation.
- Review study materials and protocols to support timeline development throughout all stages of a clinical trial.
Requirements
- Bachelor’s degree or international equivalent required; Life Sciences preferred.
- 5+ years of experience in the pharmaceutical industry and/or clinical research organization, including 3+ years in clinical study management or oversight.
- 3+ years of experience using Microsoft Project or Planisware to create, baseline, and maintain complex trial timelines.
- Experience managing multiple studies concurrently, with knowledge of clinical trial lifecycles and global or international studies.
- Knowledge of global clinical research regulatory and compliance requirements, including US CFR, EU CTD, and ICH GCP.
- Fluent business English required. Proficiency with Microsoft Suite, Microsoft Project, and SharePoint is required.
Nice to have
- Senior clinical operations experience.
- Experience across more than one therapeutic area.
- Experience with early-phase, Phase 2, or Phase 3 clinical studies.
- Awareness of local country clinical research requirements.
Culture & Benefits
- Inclusive workplace focused on diversity, belonging, innovation, and high performance.
- Annual leave entitlements and country-specific health insurance options.
- Retirement planning offerings, life assurance, and a global employee assistance programme.
- Flexible country-specific benefits such as childcare vouchers, gym memberships, travel passes, and health assessments.
- Work-life balance support for employees and their families.
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