职位描述
Essential Duties and Responsibilities
- Manage the study startup phase (e.g. protocol development, feasibility and site selection, IRB/EC/MOH approvals, and clinical supplies), the study conduct phase (e.g. enrolment and treatment (FPFV, LPLV,DBL)) and the study analysis phase (e.g. Clinical Study Report) of a clinical trial (drugs and devices)
- Able to guide a team of clinical professionals to work independently to manage all aspects of a clinical trial from site selection/vendor selection process to database lock and review of the final clinical study report. Activities including management of product inventory, forms development, enrollment, and timeline projections.
- Work with Regulatory Affairs, Medical Affairs, Global Patient Safety and other internal departments as appropriate to establish appropriate study processes to ensure compliance with guidelines and regulations.
- Manage the start-up, ongoing activities, close-down and reporting of specific research projects.
- Responsible for ensuring that clinical research material is available, distributed, used and monitored correctly.
- Work with the data management staff in the development of CRF's and programs for the appropriate data management and analysis of the collected data.
- Assist in the writing of status reports and final reports of the data and in the closing down of clinical research sites.
- Support, in close collaboration with PSM, the selection of CROs, central labs and other vendors
- Authoring and review of standard operating procedures (SOPs), standard forms and templates, and study-specific procedural documents
- Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices
- Contribute to the Global Project Team for the assigned projects (Core team member).
- Facilitate operational team meetings and support the local China clinical project teams.
- Represent LS&O in China CSO Leadership team and in other strategic working groups in Global & Asia
- Effectively manage external team/vendors activities including CRO, central lab, IRB and other external contractors
- Develop/supervise budgets, project plans and timelines for each assigned clinical study/program in China and supervise the management of the project to those commitments.
- Interact effectively with Global Senior Management to provide updates and communicate issues and opportunities.
- Ensure quality and adherence to the relevant SOPs, GCP, Regulatory guidelines and working practice
Qualifications
Knowledge of GCP, ICH guidelines and regulatory requirements, including safety reporting for clinical trials.
Demonstrated ability to present complex issues in oral and written form.
Proven people development and mentoring skills, to include field-based personnel.
Proven influencing skills in a matrix organization, through a collaborative style with the establishment of credibility and strong working relationships with cross-functional teams.
Demonstrate strong business acumen and critical thinking skills.
Process-oriented and demonstrates a sense of urgency in completing deliverables through effective goal setting and a strong result orientation
Must be able to organize, prioritize and work effectively in a constantly changing environment
Comprehensive knowledge and understanding of Asia/EU/FDA regulations and ICH Guidelines for Good Clinical Practices required as long as strong knowledge of Chinese regulations Ability to maintain effectiveness under changing circumstances and priorities.
Proactive approach, tact and diplomacy is strongly required.
Excellent verbal and written communication and organizational skills required.
Knowledge of computer software and meticulous attention to detail expected for this position.
Confident decision-making and ability to work effectively as a team leader, team member, or individually.
Proficiency in data collection design, scientific evaluation and clinical planning.
Demonstrated ability to represent Clinical Operations in local, regional and global project teams, execute clinical strategies and manage complex programs in a fast paced milestone focused environment.
Has a track record of delivering on commitments and keeping timelines.
Capable of handling (assimilating) in-depth technical information from a variety of disciplines in order to be scientifically credible within the China and Global team.
Excellent verbal and written English language skills
Degree in Science or Medical/Nursing field or equivalent
Minimum 8 years’ experience in pharmaceutical, biotechnology or medical device company including CRO.
Minimum 5 years’ experience with working in a Global environment
Knowledge of GCP, ICH guidelines and regulatory requirements, including safety reporting for clinical trials. Experience with Electronic Data Capturing (EDC) is an asset.
Comprehensive understanding of drug/device development in China
High experience with project management practices
Experience in leading a project team
Strong oral and written communications skills and diplomacy
Excellent command of spoken and written English. Other languages are a bonus
