Start Up Lead

Accountabilities:

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.