工作职责：

JOB DUTIES / RESPONSIBILITIES:
This position’s main responsibility is project management in accordance with company’s policies,
sponsor contract/requirements under applicable laws and regulations.
This position routine work is plan and Lead the Delivery of all components of a clinical study to
time, cost, and quality from study specifications through study closeout activities and/or new
drug/product approval by authority accordance with signed company contract with the sponsor.
1. Study delivery
• Planning and leading the delivery of all components of a clinical study to time, cost, and
quality per company policies and contract with the sponsor
• Conduct clinical study management related work according to company Standard
Operation Procedures (SOP), Good Clinical Practice (GCP), and other authority laws
and regulations
• Form a motivated and aligned study team that delivers the study results on or ahead of
agreed timeline with high quality & cost-effective
• Work with Line Managers/other managers to identify resource need and secure
resources from clinical operations and/or various departments
• Prepare and deliver study execution strategy, including setting study
milestone/timelines, develop recruitment strategies, quality control strategies, cost
control strategies
• Leading/preparing/contributing/training to the delivery of Clinical Study Protocol, and
delivery of other study documents (e.g. Protocol amendments, inform consent
form/amendments, site feasibility/selection package files, EC package files, other study
files, etc.)
• Produce study trackers, tools, forms and other study specific documents per study
needs
• Proactively identify risks to the project, escalate as appropriate and follow through to
resolution, develop &manage contingency risk plans to assure timely delivery to quality,
budget & time and escalate issues to stakeholders as appropriate
• Leading/managing/contributing/discussing with internal/external study
team/members/stakeholder for study status sharing, study reporting, study plan
making, documents drafting, issues escalading/resolving/tracking until closed, and/or
other stakeholders related activities
• Leading/deciding/participating in the negotiations and selection process of external
service providers/vendors per study needs
• Contributes in steering committees, submission assembly teams, regulatory defence
teams, contribute to Advisory Boards, and other activities regarding study, if needed
• Develop project management plan from time, quality and cost aspect per company
policies and/or sponsor requirements
• Leading/Supporting/approving site selection, initiation, monitoring, and closure activitiesShanghai Bestudy Medical Technology Co., Ltd Version 3.0, 01 Mar 2020
Job Description _ PM(A)D 2 / 3
• Leading/Supporting/approving study negotiation of budgets and site contracts, if
applicable
• Plan, lead and ensure appropriate training is achieved at Investigator/monitor meetings
• Leading/contributing study trainings to team member in specific therapeutic areas,
disease, protocol and other study specific processes per study needs
• Track and manage the assigned studies, work closely with study team member to
manage the planning, preparation, execution, and reporting of clinical trials ensuring
the time, quality, cost & consistency and integrity of data and safety of the subjects
• Focus on end results to be achieved, using metrics, key performance indicators and/or
other tools to manage individual and team performance within clinical studies
• Review/approve CRA's monitoring visit reports, conduct accompany site visit,
guide/coach CRA resolve issues and other activities during study executions from time,
quality, cost perspectives
• Leading/tracking/managing the study Trial Master Files (TMF) were timely and
appropriate collected, archived and transfer to sponsor per study requirements
• Leading/tracking/managing the study budget/cost were appropriate applied, arranged,
forecasted, paid, invoice collection base on aligned with sponsor and/or company
policies
• Acting as monitor 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
• Conduct any other activities regarding study delivery or line manager assigned
2. Admin works and others
• Participate in bidding activities and prepare presentation for clinical operation part if
necessary
• Interacting with CRM/CTA lead/others for sharing/improving whole team/individual
performance/capability and/or other purposes
• In liaison with Line Managers to support individual professional development through
mentoring, training and other methods
• Leading/Contributing project manager develop program/training program per function
development needs, if applicable
• Independent work/work with other members of the organization to share knowledge,
experiences and best practices
• Coaching and training the “trainees” and ensure that staff has the proper materials,
systems access and complete job responsibilities
• Review, evaluate, assess and ensure the “trainees” qualified to start work after
receiving training/learning programs
• Supervise, oversight and lead the “trainees” workload/performance/production and the
improvement plan, if applicable
• Lead/contribute to function yearly Key Performance Indicator (KPI) setting
• Lead/contribute to function yearly/half-year development plan setting
• Leading/Contributing the whole function budget, finance balance, production and/or
other finance related activities/initiatives, if applicable
• Leading/Contributing the whole function develop, quality, process optimization and/or
other initiatives, if applicable
• Evaluate application rationality and approve/reject subordinator’s business travel
application, and/or other activities per company policies and clinical trials needs
• Conduct any other activities which line manager assigned

任职资格：

Education
• Major in clinical medicine/nurse/ pharmacy/ pharmacological
or other related, clinical medicine/nurse was preferred
• At least bachelor’s degree, Master and above was
preferred. or other equivalent education background
Experience
• At least 8years or above clinical trial working experience in
CRO/Pharmaceutical company or equivalent experience
• At least 4 years or above project manager or equivalent
experience
• Candidates with Clinical research experience in
multinational pharmaceutical companies/multinational CROs
were preferred
• Candidates with PMP training certificate was preferred
COMPETENCIES/SKILLS REQUIRED:
Technical/skills Training
• Familiar with GCP, ICH-GCP and other clinical operation related guidelines/laws and
regulations
• Familiar with drug development related laws and regulations knowledge
• Familiar with project management skills and basic people management, or equivalent
manager level knowledges or skills
Language Ability
• CET-4 and above or equivalent fluent English in reading, writing and speaking, candidates
good at several foreign languages was desirable
Computer Literacy
• Proficient with laptop, familiar with varies conference systems (e.g.: Skype, Webex, etc.)
• Familiar with Microsoft office software (Word, Excel, Power Point, etc.) or equivalent
software familiar
Others
• Able to work at sites and frequently travel
• Excellent planning and implementation capacity
• Excellent communication skills and familiar with kinds of communicate methods
• Excellent coaching and guiding skills, good organization and problem-solving ability
• Build and maintain efficient working relationships with colleagues, managers and customers
• Team-work spirit, performance driven, keeping learning, self-motivated, good leadership,
accept challenges and work under pressure