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Clinical Study Manager

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Want a role with real-world impact? As an Clinical Study Manager at RB, you’ll have the freedom to develop products that improve the health of millions of lives. Worldwide. 
 
Clinical Study Manager 
Shanghai, Shanghai 

 

Accountabilities:
This is a role within the Clinical Operations team to meet business objectives through insight into Reckitt products from available data, sound oversight of clinical study activities and the generation of robust clinical study evidence.

INSIGHT

•Utilise clinical study data from previous studies for strategic use.
•Assist in giving expert operational advice (e.g. innovative approaches such as methods, models and techniques to achieve claims and endpoints) on more complex clinical topics.
•Gain strategic awareness about projects related to assigned clinical studies.

EVIDENCE 
•Lead the study teams for assigned clinical studies in a matrix structure building effective relationships with study teams, ensuring agreed timelines are met.
•Attend the Scientific Review Committee meetings and high-level strategy meetings for the assigned clinical studies.

OVERSIGHT
•Ensure that clinical activities are performed to the required standards (i.e. ICH-GCP, ISO, any local regulatory standards) and ready for inspection.
•Input into and adhere to the clinical standard operating procedures.

•Manage and oversee clinical studies (IMP, device, cosmetics) of low to normal complexity/single country.
•Assist in managing and overseeing clinical studies of high complexity/multiple regions.
•Ensure study designs and endpoints for planned clinical studies are in line with the required standards (i.e. ICH-GCP, ISO, any local regulatory standards) and are optimal for meeting the study objectives.
•Author or review Protocols.
•Author or review various other study related documentation.

Governance of vendors:
•In collaboration with Outsourcing Manager: 

 

Requirements:

•At least 1 years (Master’s degree or Bachelor’s degree) of clinical operations experience preferably in a clinical or medical department or clinical vendor.
•In depth and up to date knowledge of GCP/regulatory standards.
•Strong understanding of corporate and operational business needs.
•Project management and organisational skills.

 

Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


Job Segment: Clinical Research, Medical Research, Clinic, Healthcare

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