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4 дня назад

Local Clinical Project Manager - Sponsor dedicated (Oncology)

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
Romania
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
Local Clinical Project Manager - Sponsor dedicated (Oncology) (clinical research): Managing the local setup, execution, oversight, and delivery of oncology clinical trials with an accent on cross-functional leadership, regulatory compliance, and data quality. Focus on coordinating clinical teams, resolving site and data issues, supporting trial-site activation, and ensuring inspection readiness under ICH GCP and local regulations.

Location: Bucharest, Romania; hybrid model required. Candidates must be based in the listed location.

Company

A global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

  • Manage the local setup, execution, oversight, and delivery of assigned clinical trials.
  • Lead clinical teams and coordinate local start-up, regulatory, in-house clinical, and global staff.
  • Oversee clinical deliverables, monitoring activities, site reports, issue resolution, and data quality.
  • Identify operational risks and develop contingency and mitigation plans.
  • Maintain project-specific plans, documents, tools, training, processes, and systems activities.
  • Ensure regulatory updates, progress reports, renewals, and end-of-study notifications comply with protocols, local regulations, and ICH GCP.

Requirements

  • Bachelor’s degree in a related discipline, preferably life science.
  • At least five years of clinical research experience, including a minimum of three years in project management or equivalent experience.
  • Previous oncology experience is mandatory; immunology knowledge is desired.
  • Knowledge of ICH GCP, local regulations, drug development, clinical operations, compliance monitoring, and inspection readiness.
  • Proven ability to lead cross-functional teams and deliver clinical trials on time, within budget, and to the required quality.
  • Excellent spoken and written English and Romanian are required.

Culture & Benefits

  • Work closely with a key client’s clinical project team.
  • Opportunity to manage clinical research projects across different therapeutic areas.
  • Hybrid work arrangement in Bucharest.
  • Collaboration with international clinical, regulatory, and operational stakeholders.

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