北京招聘

Business Title: Senior Clinical Research Specialist

Purpose of the role and general description

Senior Clinical Research Specialist (CRS) will work in line with strategic priorities of MC2 Study & Scientific Solutions, promoting and implementing clinical activities in close collaboration with a staff.

Senior CRS will manage as Project Manager clinical studies on international level in cooperation with Business Units and service groups (MC2). Will participate in the management of the project from creation and revision of drafts of experiment protocols and related documents, in line with Standard Medtronic Procedure, until creation of final report and eventual scientific publication.

Senior CRS will train, educate and coordinate team involved in the studies

Responsibilities

• Defines and coordinates activities of all functions involved into implementation of Clinical Study (MC2, Legal, Quality, Regulatory)

• Puts into writing and reviews the Study Protocol and all documents related, in close collaboration with all functions involved

• Coordinates study documents’ approval process (internal and external)

• Prepares and manages Steering Committee and Investigators meetings

• Prepares documentation for authorities and coordinates approval

• Selects and qualifies hospitals and medical centres which will be participating in the Clinical Study

• Cooperates with related functions in preparation of contracts and defying legal aspects of Clinical Study

• Reviews enrolment at the site level and ensures plan are in place to meet recruitment targets

• Manages and coordinates Clinical Study, cleans data base and resolves all issue related to a quality of data gathered

• Serves as Clinical contact between Sponsor and Site Staff

• Attends study-related, organizational, departmental, and external meetings, as required

• Conducts on site Evaluation/Support Visits, as required

• Maintains strong knowledge of the study protocol, to answer questions from monitors and sites

• Collaborates and plays a role of scientific/technical matter expert in data analysis

• Formulates reports and puts in writing newsletters

• Closes the Clinical Study

• Formulates the Final Report

• Puts in writing ad hoc documents for Principal Investigators

• Oversees local clinical team activities, to achieve study timelines, quality execution and budget expectations

• Participates in the development of solutions to ensure the delivery of assigned studies on time, quality and in a cost-effective manner

• Drives the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts and progress), to ensure all study operational aspects are on track

• Evaluates potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, developing risk management plans and communicating/ escalating, as appropriate

Job qualifications

• University Masters or Bachelor’s degree in science; preferably in engineering (electronics, mechanics, biomedical field)

• General knowledge of ‘Good Clinical Practice’ and applicable regulations

• Knowledge of local requirements

• At least 5 years of experience in clinical/ biomedical field

• Experience in management of clinical studies

• Knowledge of MDT products/ therapies (matured experience in at least one therapy)

• Knowledge of ‘Good Clinical Practice and regulations related to clinical/biomedical field

• Outstanding interpersonal and communication skills

• Project Management skills

• Fluent English, both in writing and in speaking, is an absolute must have

• MS Office

Location: China

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.