Start Up Lead Specialist

hace 7 días


Madrid, Madrid, España Precision Medicine Group A tiempo completo
About Precision for Medicine

Precision for Medicine is a leading Contract Research Organization (CRO) dedicated to delivering high-quality services to the pharmaceutical and biotech industries.

Job Summary

We are seeking an experienced Start Up Lead/Senior Start Up Lead who has a passion for site start-up to join our team. The ideal candidate will work remotely in one of the following countries: UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia.

Key Responsibilities
  • Manage the site start-up process through development of an activation readiness strategy to enable oversight of site start-up delivery.
  • C coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements, and Contract Execution.
  • Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start-up activities to allow on-time activation.
  • Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start-up.
  • Partner closely with Functional Leaders and Site Start-up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
  • Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real-time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
  • Responsible for coordinating translations for documents required for submissions.
Requirements
  • Bachelor's degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
  • 5 years or more in start-up, with SU Lead or PM experience managing multiple countries in either a CRO or pharmaceutical/biotech industry.
  • Demonstrated leadership experience in driving cross-functional activities.
  • Excellent communication and organizational skills are essential.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail required.
  • Fluency in English and, for non-English speaking countries, the local language of the country where the position is based.
Salary Information

The estimated salary range for this position is $85,000 - $110,000 per annum, depending on location and experience.



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