1. People Management
• Manage CRA performance, identify gaps, if any and implement necessary actions to bridge performance gaps and encourage continuous improvements.
• Actively focus on Individual development plan within the function
• Under guidance to develop and implement rewards and recognition programs for colleagues
• Appraise performance of colleagues on the achievement of targets against predefined objectives and recommend career progression decisions.
• Demonstrate and promote DZ values and leader behaviors across all interactions.
2. Resource Management
• Prepares regular resource forecasts for CRAs.
• Responsible for timely availability of trained CRA.
• Ensures timely resource allocation for CRAs placed studies.
• Ensures optimal utilization of available resources to reach reasonable productivity in accordance with benchmarks set by country & site team leader.
• Recruitment of staff with best knowledge, skills, experience and fit for company and department
• Provides or ensures new hire trainings and any other training as necessary and track to ensure timely completion of training requirement.
3. Strategic/Policy
• As a part of Clinical Operations Management team, provide input to support strategic and tactical decisions for optimizing site management activities affecting the conduct of clinical trials.
4. Study Related Responsibilities for Clinical Trials
• Understand and ensure study delivery meet study management expectations
• Ensure an efficient interface between study management teams and monitoring team to promote teamwork, exchange of information and leverage business opportunities
• Assigns appropriate resources to studies
• Support (a)LSL to ensure study milestones and metrics are met, including;
a. Site initiation timeline
b. Recruitment target
c. Data entry and quality
d. Site issue handling including escalation of any potential safety concerns within timeline
e. TMF/ISF maintenance
f. Other key milestone set by KPI
• Ensure Monitoring Visit Reports are written in a timely manner and with quality by CRA
• Conduct accompany visit per DZ guidance to provide coaching and feedback to CRAs in site management
• Provide support to CRAs/(a)LST to ensure co-monitoring/audit findings to be addressed in a timely and appropriate manner
5. General Responsibilities
• Under country & site team lead’s supervision to implement departmental initiatives towards maximizing investigator relationships when applicable.
• Collaboration with GSL/(a)LST/QA/QC/GSA/CTA etc. to explore areas for clinical research process improvements
• Supports country & site team lead in participations/representations at professional society meetings and external trainings.
• Ensures regular communication with stakeholders regarding overall CRA capability.
• Perform any lawful and reasonable duties as assigned by supervisor or Management.
任职要求
Job Requirement
Education
• Bachelor’s degree or above
• Major in clinical medicine or pharmacology or related specialty including nursing and other biological background
Qualification
• Highly proficient in ICH-GCP and applicable regulations relating to clinical research
• Familiar with latest development in clinical monitoring tools and methodologies
• Ability to interact effectively with investigators and cross functional teams.
• Excellent people management skills with an ability to build, develop and stabilize teams comprising of both line managers and individual contributors
• Medical, scientific and technical aptitude and comprehensive and current knowledge in relevant therapeutic areas.
• Professional use of the English language; both written and oral.
• Excellent presentation and communication skills
• Strong leadership skills as well as ability to work effectively within a team environment and interact with multiple departments
• Willingness to travel
Work Experience
• Minimum 5 years’ experience in site management, preferably with proven track record 2 years in people management or project management.