Start Up Lead
P
Precision for MedicineClinical Trial Services
The position could be covered fully remotely from Serbia, Romania, Hungary, Slovakia or Poland.Full-TimeSenior
Salary209,300 - 261,600 PLN per year
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Job Details
- Languages
- Fluency in English and for non-English speaking countries the local language of country where position based.
- Experience
- 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.
- Required Skills
- Project ManagementBudget management
Requirements
- Bachelor's degree in life sciences or related field, or Registered Nurse (RN).
- 5+ years in start up, with SU Lead or PM experience in a CRO or pharma/biotech industry.
- 2+ years experience in project milestone management, resource management, and budget management.
- Proven leadership experience in driving cross-functional activities.
- Fluency in English and the local language of the country where based.
- Excellent communication and organizational skills.
- Proficiency in computerized information systems, spreadsheets, and word processing.
- Experience using milestone tracking tools/systems.
- Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
Responsibilities
- Manage the site start up process through development of an activation readiness strategy.
- Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
- Collaborate with stakeholders to secure input for milestone planning and alignment of operational goals.
- Participate in client meetings to establish expectations for delivery, communication, and risk mitigation.
- Partner with Functional Leaders to proactively identify risks to delivery and execute mitigations.
- Oversee the accuracy and completeness of tracking and systems to analyze progress metrics.
- Mentor and train staff on local study start-up regulations, submissions, and procedures.
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