【Job Summary】
This position serves as the functional head of the Clinical Operations (CO) department. The primary responsibility is to lead departmental expansion ensure high-quality study delivery aligned with business needs. Key focus areas include sponsrelationship management, study oversight, financial development, talent management, training system development, process optimization.
【Key Responsibilities 】
1、Study Oversight & Delivery Management
-Schedule & Milestones: Oversee all CO studies to ensure timely delivery. Review study status milestones via regular PM dashboards; align with sponsors on site activation recruitment execution; provide guidance intervention when study delivery falls behind schedule.
-Financial Control: Manage departmental budgets payments. Monitinternal study costs to ensure strict budget control; verify that study payments are accurately claimed from sponsors according to contract schedules.
-Quality Assurance: Ensure all studies comply with regulatory requirements, sponsor-specific quality standards, internal BESTUDY quality metrics.
2、Organizational Development & Talent Management
-Structure & HR Strategy: Evaluate adjust the COganizational structure based on business needs. Collaborate with HR/Admin on headcount control, career mapping, individual development plans.
-Performance Management: Set departmental goals; develop, review, approve KPIs performance review systems fline managers front-line staff.
-Training & Coaching: Establish comprehensive training programs covering both business soft skills; evaluate training effectiveness.
-Process Optimization: Develop regulate departmental SOPs to adapt to evolving business needs.
3、Project Leadership & Cross-functional Collaboration
-Key Account Management: Act as Project Manager fkey clients strategic projects (regardless of therapeutic area) when necessary. Ensure all clinical trials strictly adhere to protocols, company SOPs, GCP guidelines.
-Clinical Research Direct(CRD) Duties: Serve as CRD to develop, contribute to, review, approve cross-functional activities, with without HR support.
-Other Duties: Perform other related activities as required by business needs.
【Job Specifications】
1、Master‘s degree above in Clinical Medicine, Nursing, Pharmacy, Pharmacology, related fields (Clinical Medicine/Nursing preferred).
2、Minimum 10 years of clinical trial experience in a CRO Pharmaceutical company.
3、Minimum 5 years of line management equivalent leadership experience.
4、Preferred: Candidates with clinical research experience in multinational pharmaceutical companies global CROs, those with 5+ years of line management experience.
【Competencies & Skills】
1、Technical Knowledge: Solid understanding of GCP, ICH-GCP, clinical operation guidelines/regulations. Familiar with drug development laws regulations. Proficient in people management project management.
2、Language Ability: CET-6; fluent in English (reading, writing, speaking).
3、Computer Literacy: Proficient in MS Office (Word, Excel, PowerPoint) standard office software.
4、Core Competencies:
Excellent leadership skills with a track record of driving team development performance.
Strong communication, coaching,ganizational, execution abilities.
Proactive, resilient under pressure, self-motivated, embraces challenges.
Ability to build maintain efficient working relationships with colleagues, managers, clients.
Willingness to travel frequently.
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