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NV Clinical Research Project Manager

Medtronic


Location:
Shanghai
Date:
12/11/2017
2017-12-112018-01-10
Job Code:
27338
Categories:
  • Biotechnology / Science
  • Manufacturing / Production
  • Marketing
Medtronic
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Job Details

Company Medtronic
Job Title NV Clinical Research Project Manager
JobId 27338
Location: Shanghai, CHN

Description
NV Clinical Research Project Manager

Location:

Shanghai, Shanghai, China

Requisition #:

170006WB

Post Date:

Apr 25, 2017

**MAIN PURPOSE OF JOB (BRIEF SUMMARY)**

Work with theSr. Strategy marketing managerto satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies mainly in Greater China as needed.Under direct supervision, may assume project management responsibility for selected studies as a clinical study leader.

**MAIN JOB DUTIES/RESPONSIBILITIES (Please list most important duties first)**

·Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.

·Assist in preparation of sections of the Investigational Plan for assigned clinical studies.

·Assist in preparation of study materials and/or training (e.g., training of investigators, site staff and Medtronic field staff).

·Interface with, and assure training of investigators, site staff, and Medtronic clinical staff.

·Conduct site initiation (e.g. start-up document preparation, distribution, receipt, and review).Set-up and maintain accurate study status and implant logs.

·Conduct site monitoring

·Interfaces with representatives from key functional groups (Research Development, Manufacturing, Sales, Marketing, Regulatory Affairs, and European Clinical Groups).

·Assist in preparation of study budget and project plans.

·May arrange conference calls, staff meetings and training events.

·Assist in compilation and review of adverse event information.

·Assist in follow-up and resolution of site issues noted by field staff.

·Assist in compilation, review and conclusion of device complaints.

·Assist in study closure activities (e.g. close-out document preparation, distribution, receipt and review, audit and archive).

·Assist data management group with review of clinical data/information and oversight of data correction.

·Assist in preparation of annual, interim and final reports and presentations.

·Provide oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs).

·Able to refer to Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) for guidance on everyday study tasks.

·Participate in training to enhance knowledge base.

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