4 дня назад
Director, Site Start Up
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Site Start Up (Clinical Research): Leading the Site Start-Up department and coordinating regulatory submissions, site contracts, budget negotiations, and clinical trial activation across regional and global programs with an accent on GCP/ICH compliance, operational delivery, and cross-functional governance. Focus on building SSU frameworks, managing complex programs and escalations, optimizing processes, and developing KPIs, resources, and continuous improvement strategies.
Location: Remote in Australia, China, Singapore, South Korea, or Taiwan
Company
Precision for Medicine is a Clinical Research Organization providing precision medicine clinical trial, operational, medical, biomarker, and data analytics services, with a focus on rare diseases and oncology.
What you will do
- Lead the Site Start-Up department and provide guidance on project delivery, communication, resourcing, processes, systems, and performance targets.
- Oversee site start-up activities, including informed consent form adaptation, regulatory document collection and review, IRB/EC and competent authority submissions, site contracts, and budget negotiations.
- Develop the SSU framework, including intelligence, tools, methodology, risk evaluation, mitigation, and governance for regional and global programs.
- Lead delivery for large or complex SSU programs, manage escalations and remediation, and support client satisfaction.
- Partner with Clinical Operations, project management, Business Development, Global Resourcing, and regional functional leaders on planning, proposals, budgeting, and client presentations.
- Develop and report SSU KPIs, lead continuous improvement, and support team development, succession planning, engagement, and retention.
Requirements
- Bachelor’s degree in life sciences or a related field, or an equivalent combination of education, training, and experience.
- At least 12 years of clinical research experience, including extensive Site Start-Up experience.
- Extensive leadership experience, resource management experience, and a demonstrated leadership track record.
- Expert knowledge of GCP, ICH guidelines, and the clinical development process.
- Experience with strategic planning, risk management, change management, Microsoft Office, and clinical systems such as CTMS, eTMF, and EDC.
- Fluency in English required. Excellent communication, organization, attention to detail, and customer service skills are also required.
Culture & Benefits
- Remote work is available from the listed Asia-Pacific countries.
- Work is centered on quality, people, clients, and performance.
- The role supports global and regional collaboration across clinical operations and related functions.
- Equal opportunity employment and reasonable accommodation are available for applicants with disabilities.
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