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Philips Associate Clinical Operations Manager China, Shanghai 796271791
You are responsible for
The Clinical Operations Associate Clinical Operations Manager and Clinical Research Associate (CRA) and responsible for management and monitoring of clinical research studies involving human subjects from its inception to close-out according to budget and timelines.
Ensures that assigned site staff are appropriately trained to the study protocol and to ensure study and data integrity in support of a broader Clinical Evidence Strategy.
Produces work abiding by applicable Regulatory statutes (such as GCP) and withstanding scrutiny in the event of an audit.
Qualifies, Selects, Trains and Monitors internal and external study Investigators and study documentation.
Frequently interacts with subordinate supervisors and functional peer groups.
Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
Works on issues where analysis of situation or data requires review of relevant factors.
Exercises judgment within defined procedures and policies to determine appropriate action.
Sensitive to ensuring communication is clear, concise and accurate with guidance from the Manager, Clinical Operations.
Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.
Independently monitors and may execute more complex clinical studies with guidance from Leader or Manager
Typically acts as a lead, coordinating the work of Specialist or Coordinator, but is not a supervisor.
Responsible for creating monitoring reports and follow-up documentation and ensuring completion of updates in CTMSMedidata andother PIL
You are a part of
onitoring according to Regulations and Enterprise QMS.
To succeed in this role, you’ll need a customer-first attitude and the following
BS/BA in scientific or relevant discipline. GCP Certification of NMPA and Clinical Study monitoring and management training as priority considering.
Self-motivated individual who can manage multiple tasks and priorities in an efficient manner.
Able to prioritize and address delegated tasks in matrix organization.
Able to work effectively with internal and external clinical research stakeholders who need study support.
Minimum of 3+ years Prior experience providing administrative support in a clinical trial, data management or Institutional Review Board or regulatory setting.
Site assessment/monitoring experience is required.
Able to interpret content of documents to accurately file.
Highly effective organizational capability.
Able to perform document/file audits and report deficiencies to CRAs and Managers.
Clinical Operations Competencies - Apply
In return, we offer you
A path towards your most rewarding career with high level of autonomy. We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our hybrid working model is defined in 3 ways:
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