This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Start Up Lead based in the United States.
As a Start Up Lead, you will oversee and drive global clinical trial site start-up activities, ensuring efficient planning, coordination, and timely site activation. You will play a key role in developing activation strategies, managing critical milestones, and ensuring regulatory and operational requirements are met. Working closely with cross-functional teams and external stakeholders, you will proactively identify risks and implement solutions to keep projects on track. You will also serve as a subject matter expert, providing guidance, training, and mentorship to colleagues on country-specific start-up processes. This role offers the opportunity to influence clinical research delivery, strengthen operational excellence, and contribute to successful clinical trial execution in a collaborative, fast-paced environment.
- Lead the end-to-end site start-up process by developing and implementing activation readiness strategies that support timely site initiation.
- Develop, coordinate, and communicate critical path plans covering IRB/EC and CA/MoH submissions, informed consent form (ICF) customization, risk mitigation, contract execution, and investigational medicinal product (IMP) release requirements.
- Collaborate with internal and external stakeholders to establish milestones, align operational objectives, and ensure the timely delivery of site start-up activities.
- Participate in client meetings to define delivery expectations, communication plans, risk mitigation strategies, reporting requirements, and performance metrics.
- Work closely with functional leaders and site start-up specialists to identify potential delivery risks, implement mitigation plans, and protect project timelines.
- Oversee the accuracy and real-time maintenance of tracking systems and documentation to monitor progress against study, country, and site-level milestones.
- Coordinate document translations required for regulatory and ethics committee submissions.
- Maintain close communication with Feasibility, Clinical Operations, Project Management, Regulatory Affairs, and Site Contracts teams to ensure alignment on country-specific deliverables and project status.
- Act as the subject matter expert for country-level start-up requirements, including regulatory and ethics committee timelines, site contracts, budget negotiations, and IMP release milestones.
- Provide direct support for country- or site-level start-up activities when necessary.
- Contribute to the development of country-specific start-up summaries, process flows, timelines, risk assessments, and success factors.
- Support and deliver training initiatives, share best practices, and mentor colleagues on local regulations, submission procedures, internal processes, and site start-up requirements.
- Contribute to business development and proposal activities, including preparing presentation materials and participating in client presentations.
- Perform additional responsibilities as required by management.
Requirements:
- Bachelor's degree in Life Sciences or a related discipline, Registered Nurse (RN) qualification, or an equivalent combination of education, training, and relevant experience.
- At least 5 years of experience in clinical trial start-up activities, ideally in a Start Up Lead or Project Management capacity within a Contract Research Organization (CRO), pharmaceutical, or biotechnology environment.
- Minimum of 2 years of experience managing project milestones, resources, budgets, and cross-functional team activities.
- Demonstrated leadership experience coordinating multidisciplinary teams and driving complex operational activities.
- Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable clinical research regulatory requirements.
- Proven experience with milestone tracking tools, computerized information systems, electronic spreadsheets, word processing, and email applications.
- Excellent organizational, planning, time management, and prioritization skills, with a strong focus on accuracy, attention to detail, and meeting deadlines.
- Outstanding written and verbal communication, presentation, and interpersonal skills, with the ability to influence stakeholders, manage expectations, and communicate effectively across teams.
- Ability to work independently and proactively in a fast-paced environment, demonstrating flexibility, urgency, and sound problem-solving skills.
- Fluency in English is required, along with proficiency in the local language for candidates supporting non-English-speaking countries.
- An advanced degree in Life Sciences or a related field is preferred.
- Ability to travel occasionally, depending on project and business requirements.
Benefits:
- Competitive annual base salary ranging from $91,500 to $137,300 USD, depending on qualifications, experience, skills, and geographic location.
- Eligibility for a discretionary annual performance bonus.
- Comprehensive health insurance coverage.
- Retirement savings benefits.
- Life insurance and disability coverage.
- Paid parental leave.
- Paid time off, including vacation and sick leave.
- Opportunity to work remotely within the United States.
- Exposure to international clinical research projects and collaboration with multidisciplinary teams.
- Opportunities to develop leadership expertise, expand regulatory knowledge, and contribute to professional growth.
