Start Up Lead

6 hours, 9 minutes ago
Full-time
Senior
Project and Program Management
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised

Description

  • Manage site start-up processes and develop activation-readiness strategies.
  • Coordinate critical-path planning for IRB/EC and CA/MoH submissions, ICF customization, IMP release, risk mitigation, and contract execution.
  • Collaborate with clients, functional leaders, site start-up specialists, and cross-functional teams to ensure timely delivery.
  • Track study, country, and site milestones, maintaining accurate real-time data and progress metrics.
  • Coordinate required document translations and oversee site-level start-up documentation.
  • Identify delivery risks and develop and execute mitigation plans.
  • Act as a subject matter expert on country-specific start-up requirements, regulations, procedures, and tools.
  • Support country start-up summaries, process flows, training sessions, proposal activities, and direct country or site start-up work as needed.
  • Mentor and train less-experienced staff on local regulations, submissions, and start-up procedures.

Requirements

  • Bachelor’s degree in life sciences or a related field, Registered Nurse qualification, or equivalent education, training, and experience.
  • At least 5 years of clinical trial site start-up experience, ideally including SU Lead or project management experience in a CRO, pharmaceutical, or biotechnology environment.
  • At least 2 years of experience managing project milestones, resources, budgets, and team activities.
  • Demonstrated leadership experience driving cross-functional activities.
  • Knowledge of Good Clinical Practice, ICH guidelines, and applicable regulatory requirements.
  • Experience with milestone tracking tools, computerized information systems, spreadsheets, word processing, and email.
  • Fluency in English and the local language of the country of employment.
  • Excellent communication, presentation, organization, time management, prioritization, and interpersonal skills.
  • Ability to work independently in a fast-paced environment with strong attention to detail and accuracy.
  • Advanced degree in life sciences or a related field is preferred; occasional travel may be required.

Benefits

  • Fully remote work from Serbia, Romania, Hungary, Slovakia, or Poland.
  • Equal opportunity employment.
  • Reasonable accommodation available during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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