취업정보실
약학과 학생을 위한 일본계 기업 채용
참가 기업중 약학/간호학과 학생이 지원할 수 있는 기업의 있어 따로 뽑아 보내드리니
꼭 학부/학과 사이트에 게재를 부탁드리는 바 입니다.
타이틀:
-일본계 기업[시믹 코리아]2013년 3월 입사 채용 모집(CRA, DMA&STAT, QCA모집)
내용:
-회사명: 시믹 코리아(http://www.cmic.co.kr)
-회사 소개: CMIC Group은 인류에게 EBM(Evidence-Based Medicine)에 근거한 High quality of Life를 지향에 기여함에 그 가치를 두고 있으며, 더불어 제약기업의 가치를 극대화 할 수 있도록 진정한 PVC(Pharmaceutical Value Creator) Business Partner로서 신약개발 및 제조, 마케팅 등의 다양한 서비스를 제공하고 있습니다.
-응시자격:
2013년 대학, 대학원 졸업 예정자 또는 기졸자(무경력)
-약학, 간호학, 생명공학, 화학, 통계학 등 자연과학 이과계통
-영어 또는 일본어 가능자(TOEIC800이상, JLPT1급이상, JPT800이상)-직무내용: 임상 개발 업무 (임상 개발 모니터, 데이터 매니지먼트 및 통계 해석)
-모집분야
Clinical Research Department
CRA(Clinical Research Associate)
Nature and Scope
Primary activities of CRA include, but are not limited to;
1. To support the CRM, TL, PL, Director and President
・Reporting to the Clinical Research Manager (CRM) and/or Team Leader (TL) and/or Project Leader(PL)
・about progress of study
・Participation in report and protocol writing
・Participation in regulation job such as the submission of protocol
・Support of statistician in relation to construction database and study report writing
・Data input with statistician
・Participation in SOP revision
・Supporting "CMIC Korea CRC" business
2. To provide investigators and staffs with support
・coordination of study initiation meeting/investigators meeting and attendance to the meetings
・Discussion study-related problems with investigators, staffs and client if necessary
・If necessary, CRC education
・To report during clinical study to clients
・Reporting to the sponsor about progress of study through monitoring report, phone, e-mail and fax
・Report some problem including adverse events during clinical study
3. To monitor study sites and investigators to ensure consistency and reliability of the study
DM& STAT Department
DMA(Data Management Associate)
Nature and Scope
Primary activities of DMA include, but are not limited to;
1. To support the CRM, TL, PL, Director and President
・Reporting to the Pharmacovigilance/Statistical Analysis Manager(DM/STAT Manager) and/or Team Leader(TL) about progress of study
・Participation in CRF review
・Participation in data management(Unmatched Check, Logical Check and Manual Check)plan/report writing
・To prepare the Data Clarification Form(DCF)for data management
・Participation in Clinical Database design
・Participation in random allocation
・Participation in symptom coding by medical dictionary(MedDRA, WHO-ART and KIMS)
・Support of clinical study report writing
・Participation in SOP revision
・To provide Clients and staffs with support
・Discussion CRF entry rule with staffs, Biostatisticians, CRAs and client if necessary
・Reporting to the client about data management plan(DMP)
・To manage CRF, DCF and raw data of database to ensure consistency of the study
Skills Required
For scientific completeness of data management of clinical study, the DMA should
Be adequately trained for MS-Access, Visual Basic Application (VBA), clinical research and human relationship.
Be familiar with all the regulatory guidelines and procedures such as KGCP, ICH, GCP, SOP/WPDs etc.
-Attendance in public and office-scheduled education program related to clinical trial
Be knowledgeable with the logical information of CRF and protocol
Command good communication skills.
Biostatistician
Nature and Scope
Primary activities of Biostatistician include, but are not limited to;
1. To support the DM & STAT Manager
・Reporting to the Data Management / Statistical Analysis Manager and/or Team Leader(TL) about progress of study
・Participation in protocol development/CRF review
・Participation in statistical analysis plan/report writing
・To prepare the SAS procedure for statistical analysis
・To prepare study design and estimate the sample size
・to generate random allocation schedule
・Participation in random allocation
・Participation in SOP revision
・To provide Clients and staffs with support
・Discussion statistical analysis method with staffs, DMAs, CRAs and client if necessary
・Reporting to the client about statistical analysis plan(SAP)
・To manage SAP and SAS procedure to ensure consistency of the study
Skills Required
For scientific completeness of statistical analysis of clinical study, the Biostatistician should
Be adequately trained for Biostatistics, SAS/Base, SAS/Stat, SAS/Macro, clinical research and human relationship.
Be familiar with all the regulatory guidelines and procedures such as KGCP, ICH, GCP, SOP/WPDs etc.
-Attendance in public and office-scheduled education program related to clinical trial
Be knowledgeable with the logical information of CRF and protocol
Command good communication skills
Quality Control Department
QCA(Quality control Associate)
Nature and Scope
Primary activities of QCA include, but are not limited to;
1. To be responsible for
Reviewing of the approved SOPs(both general and study-specific) and amendment, and any specialized training associated with study
Observing whether there are systemic problems within a process conducted by each department: CMIC Korea employees training, compliance with SOPs and regulatory requirements, and marking documented evidence that QC was appropriately conduct on the output of each internal process as well as the final deliverable to a client
Management of project progress: guiding to prevent protocol deviations, and to have investigators complete acceptable informed consent forms, to rank priority of clinical trial process and do first, etc.
Managing all the documents generated in clinical trials under performance by CMIC Korea employees
Participation in Quality Improvement meeting
Arrangement of planning and revision of SOPs review in CMIC Korea
Operation of document transfer and archiving room management
Coordinate the special training program for specific case, intensified training for SOP and new CRA training program etc.
Managing the distributed SOPs hard copies to CMIC Korea employees
Participation in audit/inspection and Guiding CRAs for audit-inspection
To lead quality improvement of company, one should keep quality of activities in CMIC Korea through
Fully awareness of SOPs
Checking study essential document
Strengthen the compliance of SOPs
Be involved in handover process and check the handover report
Skills Required
For satisfactory accomplishment of this job, one should
Be familiar with pharmacology, other disciplines related to health issues, and clinical research.
Be well recognized all the regulatory guidelines and requirements in conducting clinical trials such as KGCP, ICH/ GCP, SOPs etc.
Be knowledgeable about the information of study drug and be well comprehensive about protocols
Have good communication and interpersonal skill
-지원절차: http://2012.japan-careerproject.com/recruit/-2013-1
