채용 공고

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1. Position: DM Manager(Data Management Manager), 0 명 ( 경력 )

2. Job Requirement
At least 5 years of experience working on clinical trials with leadership capacity.
Degree over than Bachelor of Science
At least 5 years of experience of EDC system expertise
Good command of English is a must
Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
Advanced knowledge and understanding of clinical trials
Advanced knowledge and understanding of DM process
Advanced knowledge and ability on programming (SAS, SQL, XML etc)

3. Job Description

1) Team Management
Promote staff’s performance and quality
Resource planning and managing

2) Project Management
Ensure the data management process for each project based on SOPs & contract is qualified and validated.
Ensure that DMP describes proper DM process for complete, integrity, consistent data.
Ensure that Data Validation Specification process include EDC system validation check.
Ensure that Data Management Scope check co working with BD team.
Develop that New business model co working with BD team.
Ensure that medical data review (including medical coding) is performed in proper manner.
Ensure that other DM processes (blind data review, data QC, DB lock etc) are performed as SOPs.
Appropriate communication with CR team on data management issue

3) Training
Ensure that the DM and related SOP training is provided periodically
Ensure that the SDTM training for advanced DM staffs
Ensure that proper (internal or external) training course is provided based on each staff’s role & capacity. Especially; For ALL Staffs
Understanding general clinical trial process including SOPs and regulatory guideline (ICH guideline GCP etc)
Understanding DM/STAT/CSR process For Data Management Associate
Understanding each phase clinical trial study process
Knowledge of data validation; especially of GCDMP
Knowledge of EDC system validation
Knowledge of Manual Review specification including coding process For Data Management Project Leader
Knowledge of communication skill with sponsor / operation team
Knowledge of project team work leading each project data management status
Knowledge of blind data review skill each project data management For Data Coordinator
Understanding of data coordinator process and QC of data management support documentation

4) Audit/Inspection Coordination
Overall preparation in DM related audit/inspection and ensures complete resolution and closure of issues of findings and observations

4. Job Information
- 고용형태: 정규직
- 연봉: 면접 후 협의

5. Guidelines for Applicants
- 접수기간: 채용 시 마감
- 지원방법: 자사 홈페이지(www.cnrres.co.kr ) 를 통해 입사 지원
- 전형절차: 서류전형-1차 면접-2차 면접-최종합격
(*서류 심사 합격자에 한하여 1차 면접 심사 여부 유선 통보)

6. Contact Information
- 관련문의: 인사담당자 E-mail recruit@cnrres.co.kr