- Has regulatory oversight of direct reports by ensuring regulatory training is executed, understood and implemented
- Escalate issues and follow them till proper resolution
- Ensures training record compliance with training matrix and ensures training records are up to date
- Provide input to relevant SOPs and standard plans/templates when applicable
- Assist with coordination and implementation of on-boarding of new direct reports ensuring GCP training before study-related activities begins
- Hold staff accountable for issue escalation to the management team, the sponsor and QA, as appropriate and determine regional implications for corrective action plans
- Hold staff accountable for quality and compliance with project plan and adherence to contract obligations
- Coach staff to own effective Investigator relations and Investigator oversight when applicable
- Report status of assigned workload of direct reports and ensure allocation reports are updated
- Perform weekly review of direct report billable hours and utilization (in context of project allocation, supply and demand); escalate of outliers and assists management team for mitigation
- Adheres to global tools for monitoring and utilization forecasting
- Assist with staff recruitment through screening and interviewing
- Financial authority in accordance with current signature approval matrix
- Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports
- Liaise with internal and external customers in relevant process improvement initiatives
- Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity
- Support the company/department processes (e.g. Quality Control Visits)
- Identify, develop, and implement measures to improve the efficiency of the department
- Responsible for staff time management, PTO and salary reviews
- Might be requested to work in a client facing environment
- Perform other duties as required by Management
- 5 years or above Clinical research associate experience or combined with other relevant experience (i.e. worked as a Clinical Team Leader/Project Manager at a Pharma company or CRO)
- At least 1 year or above CRM experience
- Individual proficiency with managing direct reports or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Master/Bachelor degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory)
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FSP-Clinical Research Manager - Beijing, 中国 - Fortrea
描述
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Essential Job Duties:
Experience:
Minimum Required:
Education/Qualifications/Certifications and Licenses
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
