HOMEJob Description
CTM
Clinical Trial Management
SSUA/SSUM (Study Start Up)
Job Specifications
- IRB initial submission & approval
- Site budget negotiation
- Site contract
Preferred Qualifications
- Candidates who have completed the basic education for CRA are preferred
Related Majors
- Persons who majored in the fields of life sciences including pharmacy, nursing, biology, and clinical pathology
CRA
Job Specifications
- Management and maintenance of clinical trial documents
- Submission of documents including protocol amendments and SAEs to IRB, and conduct of the process to obtain IRB’s approval for amendments
- Conduct of PSSV, SIV, monitoring, and COV
- Grasp of subject enrollment status and potential risks through regular meeting with investigators and discussion on them with the CRM
- Execution of projects in compliance with the timeline and schedule established within a study team
Preferred Qualifications
- CRC or CRA with experience
- Candidates who have completed a training for CRAs employed in clinical trials
CRM
Job Specifications
- Responsibility for overall project management at site level
- Maintenance and management of the qualities of monitoring activity and CRF data
- Management of subject enrollment status and proposal of strategies for subject enrollment
- Conduct of PSSV, SIV, and monitoring, and review of COV reports
- Supervision of blind meetings for DBL
Preferred Qualifications
- Candidates with experience in project management or CRM
- Candidates fluent in English
Related Majors
- Persons who majored in the fields of life sciences including pharmacy, nursing, biology, and clinical pathology
CDM
Clinical Data Management
CDA/CDM
Job Specifications
- Management of DCFs/queries
- Medical Coding
Preferred Qualifications
- Candidates who can use EDC(eCRF) are preferred
- Candidates with experience in CRF development and clinical data management are preferred
- Candidates with experience in conducting clinical trials
- Candidates fluent in English are preferred
DBA/DMM
Job Specifications
- Development/operation of clinical data management system
- Handling of clinical data
Preferred Qualifications
- Candidates who are at advanced level for at least one of the web-based programs are preferred ( C#, .net and MS-SQL, and Oracle are preferable)
- Candidates with experience in the task relevant with clinical data management system (EDC) are preferred
- Candidates at advanced level for data handling are preferred
- Candidates fluent in English are preferred
IT
Job Specifications
- Management of IT infrastructure including overall server network and storage
- Planning and set-up of new systems
- Support for internal users
Preferred Qualifications
- Candidates with a certificate of CCNP, CCNA, or MCSE are preferred
- Candidates with work experience at global companies are preferred
MW & RES
Medical Writing & Research
Medical Writer
Job Specifications
- Designing of clinical trials and development of protocols
- Development of consent forms
- Preparation of clinical study reports
- Preparation of Common Technical Document (CTD) Modules 2.5/2.7/5
Preferred Qualifications
- Candidates with working experience in medical writing for clinical trials
- Candidates fluent in English
Related Majors
- Persons who majored in the fields of life sciences including medicine, pharmacy, nursing, veterinary medicine, and biology
PM
Project Management
PM
Job Specifications
- Conjunction with the project team
- Development of the project plan based on understanding of the client’s project milestone
- Supervision of the project plan development and motivation for the project team to achieve the target
- Provision of project progress reports on project activities to the senior management as requested
- Performance of a lead role in a study or a series of studies and provision of strategic and tactical planning, organization, direction, and tracking required to complete a study or a series of studies within a project
- Performance of a role as the primary project contact for communication
- Facilitation and fosterage of positive and productive communication among the client, other functional groups, and project team
- Development and implementation of a project-specific communication plan in agreement with the client
- Monitoring of the progress in a project and identification of hurdles, issues, and changes against the plan for the project
- Organization of the regular internal/external project team meetings including face to face meetings and teleconference
Preferred Qualifications
- Candidates with experience in project management or as CRM
- Candidates fluent in English
Related Majors
- Persons who majored in the fields of life sciences including pharmacy, nursing, biology, and clinical pathology
PS
Job Specifications
- Assistance in creation, maintenance, and archiving of a variety of databases and systems (e.g. eDOC, CTMS, etc.)
- Support for the users and onboarding of new team members granting them access to appropriate systems (e.g. eDOC, CTMS, etc.)
- Management of the registration center to ensure screening and enrollment according to the protocol
- Handling of financial processes for study-related payments
(site payment, transportation fee, consultancy fee, vendor payment, etc.) - Handling of the amendment to the site contract with CRA
- Handling of the customs clearance for all the study related supplies (study drugs, equipment) in cooperation with couriers
- Cooperative work with the project PM to deliver the recurrent tasks in a timely and highly accurate manner consistently
- Participation in the process improvement initiatives as requested
Preferred Qualifications
- Candidates with experience as CRC or CRA
Related Majors
- Persons who majored in the fields of life sciences including pharmacy, nursing, biology, and clinical pathology
STAT
Statistician
Job Specifications
- Consultation on designing clinical trials and statistics-related matters
- Calculation of the number of samples
- Development of randomization plan and generation of random numbers
- Development of the statistical analysis plan
- Conduct of statistical analyses and preparation of statistical analysis report
- Generation of CDSISC ADaM
Preferred Qualifications
- Candidates with working experience in statistics in association with pharmaceutical industry are preferred
- Candidates experienced in statistical analysis tools (SAS/R/SPSS, etc.) are preferred
- Candidates experienced in computer languages (VB, C#, JAVA, etc.) are preferred
Related Majors
- Persons with bachelor’s/master’s degree in statistics (persons with master’s degree in medical statistics or related fields)
SP (Statistical programmer)
Job Specifications
- Macroprogramming of statistical analyses using the SAS
- Generation of the tables, figures, and data listings from the results of statistical analyses using the SAS
- Generation of CDSISC ADaM
Preferred Qualifications
- Candidates experienced in statistical analysis tools (SAS/R/SPSS, etc.) are preferred
- Candidates with experience in computer programming are preferred
- Candidates experienced in computer languages (VB, C#, JAVA, etc.) are preferred
Related Majors
- Persons who majored in statistics or computer science related fields
ER
Epidemiological Research
ER SSUA/SSUM
Job Specifications
- Management of the initial review by IRB and contract with sites for non-interventional studies (observational study, rPMS, etc.)
Preferred Qualifications
- Candidates with work experience relevant with IRB, contract, and document management
- Registered nurses (bachelor’s degree or equivalent academic background) are preferred
Related Majors
- Persons who majored in the fields of life sciences including pharmacy, nursing, biology, and clinical pathology
ERA/PL/ERM
Job Specifications
- Performance of the tasks for observational study/epidemiologic study/PMS
- Preparation for and submission of IRB application documents
- Conduct of study initiation visit and training of subinvestigators
- Conduct of monitoring/close-out visits to study sites
- Support for resolution of queries
- Conduct of in-house monitoring utilizing EDC
- Development of project management plan
- Management of study documents
Preferred Qualifications
- Candidates with experience in PMS, OS, and clinical studies on medicinal products
- Candidates who have completed a training for CRAs employed in clinical trials
- Candidates fluent in English
Related Majors
- Persons who majored in the fields of life sciences including pharmacy, nursing, biology, and clinical pathology
PV
Pharmacovigilance
PVS/PVM
Preferred Qualifications
- Candidates with at least 2 years’ of experience in clinical trials on anti-cancer drugs (CRC or CRA) are preferred
- Candidates with a pharmacist license are preferred
- Candidates fluent in English are preferred
SC
Strategy Consulting
RAA/RAM (Regulatory Affairs)
Job Specifications
- Conduct of the tasks related to the application for IND approval
- Conduct of the tasks related to the application for issuance of the certificate of investigational medical device
- Conduct of the tasks related to the application for NDA approval
- Consultation on the strategies for approval and development of medicinal products
Related Majors
- Persons who majored in the fields of life sciences including medicine, pharmacy, pharmacology, and veterinary medicine
QA
Quality Assurance/Audit
QA auditor/QAM
Job Specifications
- Conduct of internal audit of and suggestion of improvement plan for clinical studies
- Assessment of vendors in clinical studies
- Review and management of SOPs
- Handling of audits and inspections by clients
- Provision of QA services in response to clients’ requests
- Conduct of all sorts of activities for quality management
- ISO9001 품질경영시스템 인증 유지
Preferred Qualifications
- Candidates with knowledge of the procedure for clinical trial/process and technique of audit
- Candidates with experience in clinical trials (CO, DM, and PV areas) or in audit/QC are preferred/
- Candidates credentialed as RQAP-GCP or RQAP-GVP are preferred.
- Candidates fluent in English
Related Majors
- Persons who have pharmacy, nursing, and public health related majors
C&MC
Compliance &
Management Consulting
C&MC Auditor
Job Specifications
- Conduct of internal audits and management consultation
- Investigation into and prevention activities against corruption
- Inspection of and suggestion of improvement plan for processes
- Review of the efficiency and validity of internal control
- Risk assessment through data analyses and management of proposals for improvement, etc.
- Conduct of all sorts of activities for quality management
- Conduct of tasks for and management of ISO 37301 accreditation
Preferred Qualifications
- Candidates possessing knowledge related to tasks/rules/regulations/financial affairs/process improvement
- Candidates with knowledge of audit technique and instructions on audit tools
- Candidates with a concept of internal control
- Candidates with experience in internal audit or work experience in planning or at consulting firm are preferred
- Candidates credentialed as CIA or CISA are preferred
- Candidates fluent in English
Related Majors
- Persons who majored in the fields of business, law, and politics
TRA
Training
TRA
Job Specifications
- Development, operation, and evaluation of education programs
- Operation of education management system
Preferred Qualifications
- Candidates with an education related certificate are preferred
- Candidates capable of communication in English
Related Majors
- Persons who majored in business administration, public administration, and education
BD
Business Development
BDA/BDM
Job Specifications
- Preparation of quotation for, negotiation on, and management of clinical project
- 제안서 작성 및 미팅진행 (Presentation)
- 과제 수주와 관련된 내/외부 커뮤니케이션
- 시장상황 및 정보를 바탕으로 신규 비즈니스 모델 개발
- 중/장기적 성장전략에 부합하는 스폰서 네트워킹 관리
Preferred Qualifications
- Candidates with work experience in marketing/sales/development at pharmaceutical companies and with knowledge of and experience in clinical trials are preferred
- Candidates proficient in communication skills are preferred
- Candidates with work experience in the business development for a clinical CRO are preferred
CM
Contract Management
CMA/CMM
Job Specifications
- Conclusion of domestic/international contracts
- Settlement of and claim on sales
Preferred Qualifications
- Lawyers are preferred
- Candidates with experience in pharmaceutical industry are preferred
- Candidates with experiences in the conclusion of contracts and work experience at multinational companies are preferred
- Candidates fluent in English are preferred
97 Toegye-Ro, Coryo Daeyungak Tower, 16th Fl., Jung-Gu, Seoul 04535 Korea
- MAIN :
- 82.2.546.1008
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- 82.2.584.9008
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