Medical - Clinical Operation Manager - Shanghai

KEY ACCOUNTABILITIES:

• Give clinical operation management for Clinical trial to align with business strategy:

• Work with medical manager teams to set up the Clinical trial review and management module in Medical

• Maintain and update study files which kept by Sanofi and required with SOP

• Track Clinical trial study status and update monthly report

• Review investigator proposed budget, make SPE and payment by milestones

• Clinical trial status and documents management in Vision Tracker and ClubNet system

• Support to strategic clinical operation input for new ISS study planning at early stage. Initiate internal process of medical communications projects, including procurement, legal and other processes as needed;

• Follow project approval, delivery, payment and documentation process

• Support document management needs of management information system of clinical projects and RWE projects

• Undertake other team management assignment as required

• Liaise with Medical Managers, CSU/CSO to ensure proper planning and execution of CEM Medical or China 2030 funded studies according to business priorities, agreed timeline and budget

• Clinical studies planning according to agreed business priorities

• Clinical study commitment form agreed with all key stakeholders

• Clinical study budget management:

o Budget evaluation ( FXX.1, FXX.2 etc.) / Budget transfer & increase / Budget follow up

o SPEs of funded studies submission (including re-submission) and identify potential issues

• Contact person for Controlling, CSU and CSO, CEM Global Medical, GBU Medical and SRC

• Communication with CSU about resources & outsourcing for new study development

JOB-HOLDER ENTRY REQUIREMENTS:

Education: Bachelor’s degree in science or social science, medical or biochemistry background preferred.

Experience & knowledge:  

• 6 year above working experience in pharmaceutical/healthcare industry

• Minimal 4 years of experience in clinical trials

• Independent project management experience with at least two projects lasted for six months, and with more than five different stakeholders

Core competencies:

• Excellent spoken and written English and mandarin

• Mature personality with good communication, interpersonal and networking skills

• Working under pressure

• Fluent English

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