Start Up Lead
New
P
Precision for MedicineClinical trial services
Remote, United StatesFull-TimeLead
Salary$91,500 — $137,300 USD
Apply NowOpens the employer's application page
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
- Cross-functional Team LeadershipBudget management
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; SU Lead or project management experience in a CRO, pharmaceutical, or biotechnology setting is ideal.
- At least 2 years of experience in project milestone management, managing resources and budgets, and coordinating team activities.
- Demonstrated leadership driving cross-functional activities.
- Experience using milestone tracking tools or systems.
- Experience with 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 based.
- Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements.
- Advanced degree in life sciences or a related field is preferred.
- Occasional travel may be required.
Responsibilities
- Develop activation-readiness strategies and oversee site start-up 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 plan milestones and align operational goals for timely site activation.
- Participate in client meetings to establish delivery expectations, communications, risk strategies, reporting, and metrics.
- Identify delivery risks with functional leaders and site start-up specialists, and develop and execute timeline mitigations.
- Oversee accurate, real-time tracking and systems for progress metrics at study, country, and site levels.
- Coordinate translations for documents required for submissions.
- Maintain communication with feasibility, clinical operations, project management, regulatory, and site contracts teams on project status and deliverables.
- Act as the subject matter expert for site-level critical paths and IMP release data, and support country- or site-level activities as needed.
- Support country start-up guidance, training, staff mentoring, and client proposal activities.
View Full Description & ApplyYou'll be redirected to the employer's site
