工作职责：

JOB DUTIES / RESPONSIBILITIES:
This position will be the line Manager of CTA-I, CTA-II & SCTA. The main responsibilities are
people management in accordance with company’s policies and applicable laws and
regulations, assisting clinical trial execution, and/or admin works.
This position routine work mainly focus on staff performance management, staff development,
coaching and training, work allocation and other admin/non-admin works, such as planning,
assigning and adjusting employee’s work, driven performance, guiding professional
development, awarding and disciplining employee’s, help and/or guide subordinate resolving
problems, etc.
1. Employee Performance Management
• Assign subordinator into one or several clinical trial for take CTA responsibilities
according to study needs and candidate qualifications
• Setting and guiding subordinator yearly objective and performance target according to
company policies
• Regular conduct staff’s annual performance review and/or irregular performance review
per company policies
• Regular review subordinator workload and adjust staffs if needed
• Regular review subordinator responsible clinical trial quality/files/trackers and any other
trial related according to study needs and company policies
• Regular conduct the one on one talk with subordinator to find out the employee’s
concern and provide coaching and guiding for individual performance improvement
• Regular/irregular reviewing, managing and/or evaluating whole team/individual
production per company policies, making, executing the improve plan until production
meet business/company needs and ensure whole team/individual keeping production, if
needed
• Contribute to function yearly Key Performance Indicator (KPI) setting, if applicable
• Conduct any other activities regarding employee performance review
2. Staff Development
• Lead and ensure the whole team a good and scientific development within company
policies
• Lead and setting a scientific talent develop plan for individual & company develop
needs
• Setting and guiding subordinator yearly/half-year individual development objective, if
needed
• Regular review individual development plan with subordinator and/or irregular review
within company policies
Shanghai Bestudy Medical Technology Co., Ltd Version 3.0, 01 Mar 2020
Job Description _ CTAL 2 / 3
• Regular conduct the one on one talk with subordinator to find out the employee’s
concern and provide coaching and guiding for individual development
• Conduct any other activities regarding staff development
3. Coaching and Training
• Conduct and/or ensure new onboard employee participate in the function
implementation training for new staff and ensure that staff has the proper materials,
systems access and complete job responsibilities
• Conduct onboarding training for new staff in conjunction with HR/Quality
Control/Training and/or other departments requirements
• Review, evaluate, assess and ensure new onboarding employee qualified to start work
after receiving training/learning programs
• Regular and/or irregular provide trial related/non-trial related/soft skill training to whole
team/individual per business needs, employee capabilities, experience sharing and/or
other purposes
• Oversight whole team/individual for training plan receiving, SOP reviewing and any
other business needs training receiving, as applicable. Ensure whole team/individual
qualify to company/clinical trial requirements
• Acting as CTA per business /clinical trial needs to improve whole team/individual
capabilities, efficiency, a clinical trial execution, quality, process initiatives and/or other
purposes, if needed
• Assist to preparing/preparing/organize CTA training and/or other trainings, if applicable
• Assist to/Participate in training and mentoring of new staffs ensuring compliance with
ICH/GCP, company SOPs and/or company policies, if applicable
• Conduct any other activities regarding training and coaching
4. Admin works and others
• Guiding/directing new onboard employee to other staffs, if needed
• Directing and ensure the new onboard staff has the proper office materials, systems
access and/or other needs, ensure the new onboard staff ready to start assigned work
• Assist HR/Admin/IT/other departments to ensure new onboard staff familiar with
company, working process and/or other requirements per employee start work needs
• Attending/introducing CTA related work and/or provide related process/files to
auditors/inspectors/sponsors for business needs, if applicable
• Manage and appraising staffs' resource allocation to ensure reasonable work
arrangement of whole team/individual
• Interacting with global/local study leader/Project managers/others for whole
team/individual performance/capability and/or other purposes
• Participating in the job vacancies candidate selection, conducting candidate CV review,
interviewing candidate, provide feedback and nominate candidate to next round
interview per company policies
• Discussing/reporting/guiding/addressing employee related issues, provide the feedback
and track status, if needed
• Contract staff management according to scope of contract and company policies
• Contributing/leading the whole function develop, quality, process optimization and/or
other initiatives
• Assisting company/HR/CRD for employee salary management, staff promotion, and/or
other function/people management related activities base on company policies
• Awarding and disciplining employees, if applicable
• Evaluate application rationality and approve/reject subordinator’s business travel
application, annual/personnel/other leave, and/or other activities per company policies
• Conduct any other activities which line manager assigned or per CTAL work needs

任职资格：

Technical/skills Training
• Familiar with GCP and International Conference on Harmonization (ICH) guidelines
• Familiar with drug development related laws and regulations
• Basic knowledge with people management or equivalent manager level knowledge or skills
Language Ability
• CET-4 and above or equivalent fluent English in reading, writing and speaking
Computer Literacy
• Proficient with computer/laptop
• Familiar with Microsoft office software (Word, Excel, Power Point, etc) or equivalent
software familiar
Others
• Good at varies kinds of excellent/effective communication skills
• Good organization and logistic/time arrangement ability
• Good coaching and guiding skills, good problem-solving ability
• Team-work spirit, ability to build and maintain efficient working relationships with colleagues,
managers and customers
• Performance driven, keeping