Medical - Assoicate Clinical Operation Manager - Shanghai

Key Accountabilities

Given study operation management to align with business and medical strategy:

1.      Work with MO head to safeguard on-time delivery of all key milestones of study, review process and eliminate any bugs to avoid any risks of potential delay of study

2.      Lead medical operation team to manage smooth and productive cooperation within MA and with CSO/CSU and global line functions to ensure timely completeness of study set-up, SRB process, PRC process

3.      Work together with CSO PL to track study progress and support to maintain smooth supply of IMP, documentation and storage

4.      Be responsible for maintaining and updating MA study SOPs

5.      Track study status and update monthly performance report

6.      Review investigator proposed budget, make AED and payment by milestones

7.      Ensure all ISS/CSS status and documents management in ClubNet system

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

9.      Follow project approval, delivery, payment and documentation process

10.   Support document management needs of management information system of clinical projects and RWE projects

11.   Undertake other team management assignment as required

Liaise with Medical Managers, CSU/CSO to ensure proper planning and execution of China Pharma Ops funded studies according to business priorities, agreed timeline and budget:

1.      Clinical studies planning according to agreed business priorities

2.      Clinical study commitment form agreed with all key stakeholders

3.      Clinical study budget management:

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

b)       AEDs of PO funded studies submission (including resubmission) and identify potential issues

4.      Contact person for Controlling, CSU and CSO, and global lines

Communication with CSU about resources & outsourcing for new study development

Job-holder’s Requirements

Education

Bachelor’s degree in medicine or biology

  Entry qualification

• 5 year above working experience in pharmaceutical/healthcare industry Minimal 2 years of experience as medical manager, or Minimal 2 years of experience in CRO
• 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 People management skills
• Working under pressure

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