Loading...
Share this Job
Apply now »

Cluster/Country Clinical Research Manager

Your Role:

  • Accountable for day to day activities of all aspects for the management of local and/or regional company sponsored studies, including study plans, timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
  • Accountable for the  oversight of ISS granted by our company,  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
  • Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
  • Develop and monitor study budget and timelines
  • Monitor work 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 
  • Provide product expertise and/or oversight at the country level to external consultants and/or flexible staff working on company sponsored clinical studies
  • Lead at the regional level early access programs in collaboration with the Product CRM Lead.
  • Understanding of local / country and regional requirements for clinical trials 
  • Managing and steering CROs 
  • Proactive issue monitoring and management
  • Manages the budget for all local clinical studies  in own country, regional study in own hub, and Global Phase IV studies as well as the IST/ISS grants
  • Coordinate within own region the study management for all local and regional clinical trials across all phases and therapy areas, as well as IST/ISS and EAP activities
  • Support local and regional organizations in delivering local medical strategy across the portfolio within own region
  • Work with CRO/external consultantis in country / region to ensure local / regional trials are delivered within desired quality, timelines, and costs
  • Act as an interface between Global Clinical Operations and local organizations (Global Operations)
     

 

Who You Are:

  • Medical or Life Sciences degree or equivalent qualification
  • At least 8 years of experience in clinical research in a CRO, pharma or biotech company 
  • Good understanding of APAC regulatory and local requirements for clinical trials
  • Thorough knowledge of ICH GCP 
  • 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 judgement
  • Fluency in English (oral and written) plus local language

 

•보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.

•지원서의 기재사항이 사실과 다른 것으로 확인되거나 Reference from previous employer 상에 채용상의 결격사유가 확인될 경우 합격 또는 채용이 취소될 수 있습니다

•(The company reserves the right to withdraw the offer, it if discovers subsequently that a candidate has given false information in application or has provided false or fraudulent documentation in support of his/her application. The offer is conditional upon satisfactory results of reference checks.)

 

 

Job Requisition ID:  203425
Location:  Seoul - all
Career Level:  E - Professional (10+ 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, Medical, Biotech, Clinical Research, Healthcare, Science, Research

Apply now »