Start Up Lead
New
P
Precision for MedicineClinical trial services
Location: Remote, United StatesFull-TimeLead
Salary$91,500 — $137,300 USD
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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; 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.
- Required Skills
- Cross-functional Team Leadership
Requirements
- Bachelor’s degree in life sciences or a related field, Registered Nurse (RN), or equivalent combination of education, training, and experience.
- At least 5 years of start-up experience, ideally as an SU Lead or PM in a CRO, pharmaceutical, or biotechnology industry, or equivalent relevant experience.
- At least 2 years of experience in project milestone management, resource and budget management, and coordinating team activities.
- Demonstrated leadership experience driving cross-functional activities.
- Experience using milestone-tracking tools or systems.
- Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.
- 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 applicable regulatory requirements.
- Preferred: advanced degree in life sciences or a related field.
- Occasional travel may be required.
Responsibilities
- Manage the site start-up process by developing an activation-readiness strategy and overseeing delivery.
- Coordinate and present critical-path plans covering IRB/EC and CA/MoH strategy, ICF customization, risk mitigation, IMP release requirements, and contract execution.
- Collaborate with stakeholders to plan milestones and align operational goals for timely site activation.
- Participate in client meetings to establish delivery expectations, communication, risk mitigation, status reporting, and metrics.
- Partner with functional leaders and site start-up specialists to identify delivery risks and execute timeline mitigations.
- Oversee accurate, real-time tracking and systems updates to analyze progress against targets at study, country, and site levels.
- Coordinate translations for documents required for submissions and communicate project status with country start-up functions.
- Act as subject matter expert for site-level critical-path and IMP-release data, including local review timelines, contracts, and budget negotiation requirements.
- Support country-specific start-up summaries, process flows, training, mentoring, and client proposal activities.
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