Clinical Research Manager / Senior Clinical Research Manager

Posted 25 Mar 2020

Beijing - all, Beijing - China

Req Id 205023

Details

A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:

KEY ACCOUNTABILITIES  

 • Accountable for the  oversight of ISS,  including the support of the set-up  and  operational assessment of investigator-sponsor,  tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report 

• Accountable to discuss with Sponsor-Investigators operational aspects of ISS

• Develop and monitor study budget and timelines as per discussions with Investigator-Sponsors

• Monitor work performed by Investigator-Sponsors to ensure quality 

• Ensures that trial status is tracked and entered into the respective Clinical Trial Management System  

• Contribute to the planning and set-up of a study  and provide planning parameters 

• Support early access programs on the country level  

• Act as a Subject Matter Expert in one or more supportive areas, such Trial Master File, Site budget development and Clinical Trial Agreements, and more specifically

o Develop expertise in the assigned area of responsibility, and be the primary point of contact for other RCO team members on the specific topic o Act as the main liaison between RCO team members and other internal functions as appropriate

o Perform at a global/regional level all related activities across a number of company-sponsored studies and/or ISS  

 • Understanding of local / country requirements for clinical trials  

• Networking skills to represent company with key local stakeholders

• Proactive issue monitoring and management 
• Manages the budget for all ISS grants. 
• Coordinate within own country study management for all local clinical trials across all phases and therapy areas ISS grants. 

• Support local organization in delivering local medical strategy across the portfolio within own country 

• Work with internal functions in county and globally to ensure local ISS are delivered within desired quality, timelines, and costs 
 
SCOPE OF PEOPLE RESPONSIBILITY
• Act as an interface between Global Clinical Operations and local organizations (Global Operations)
 
COOPERATION 

Internally   • Country organization  • Medical Affairs (HQ and country)  • Financial Planning and Analysis  • Local and Global Drug Safety  • Other global functions incl. Biostats, Global Clinical Data Sciences, Medical Writing, etc • Service Provider Management (SPM)  • Legal  • Finance 

Externally • CROs and other service providers   • Medical experts/Key Thought Leaders   • Investigators and clinical site personnel   • Representatives of institutions/hospitals    
 
Who you are:

• Bachelor degree in Medical or Life Sciences. Equivalent qualification may be also acceptable depending on work experience
• At least 5 years of experience in clinical research in a CRO, pharma or biotech company  

• Experience in clinical trial planning and conduct  

• Thorough knowledge of ICH GCP and applicable local regulations  

• Demonstrated good interpersonal skills  

• Demonstrated good written and verbal communication skills  

• Demonstrated good presentation skills  

• Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way  

• Analytical skills, quick perception and good judgment 

• Fluency in English (oral and written) plus local language

 

HR: 95598

Functional Area: Research & Development


What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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