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Clinical Research Manager / Senior Clinical Research Manager

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

Job Requisition ID:  205023
Location:  Beijing - all
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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

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