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Start up Lead

1 hour, 44 minutes ago
Turkey
Senior
Program Manager
Project and Program Management
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 137

Description

  • Manage the site start-up process through an activation readiness strategy that supports oversight of delivery.
  • Coordinate critical path planning for IRB/EC and CA/MoH strategy, ICF customization, risk mitigation, IMP release requirements, and contract execution.
  • Collaborate with stakeholders to gather input for milestone planning and align operational goals for timely site start-up delivery.
  • Participate in client meetings to define expectations for communication, reporting, metrics, and risk mitigation.
  • Partner with Functional Leaders and Site Start Up Specialists to identify delivery risks and implement mitigation plans.
  • Maintain accurate real-time tracking systems and status data to monitor progress against study, country, and site timelines.
  • Coordinate translations for documents required for regulatory submissions.
  • Work with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams on project status and deliverables.
  • Serve as subject matter expert for country-specific site start-up activities and IMP release data points, including local ethics timelines, reviews, contracts, and budget negotiations.
  • Support site- and country-level start-up activities when needed and contribute to country start-up summaries, process flows, training, and staff mentoring.

Requirements

  • Bachelor’s degree in life sciences or a related field, RN, or an equivalent combination of education, training, and experience.
  • Experience in site start-up from a CRO or pharmaceutical/biotech environment.
  • 2+ years of experience in project milestone management, including managing resources, budgets, and team activities.
  • Demonstrated leadership experience driving cross-functional activities.
  • Excellent communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, email, and milestone tracking tools/systems.
  • Fluency in English and, for non-English-speaking countries, the local language of the country where the position is based.
  • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
  • Ability to work independently in a fast-paced environment with strong attention to detail, accuracy, time management, and prioritization.
  • Advanced degree in life sciences or a related field is preferred.

Benefits

  • Remote work indicated by #LI-Remote.
  • Opportunity to work for Precision for Medicine in a global clinical trial start-up role.
  • Occasional travel may be required.

Interested in this position?

Apply directly on the company website

Apply Now

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