명동에 위치하고 있는 임상시험 회사, LSK GLOBAL PS (엘에스케이글로벌파마서비스) 에서 영어 능통한 교민 출신 직원을 채용 중 입니다. 

본인 혹은 자녀분 들이 한국에서 몇년 생활하면서 직장 다니고 싶다 하시면 더욱더 좋은 기회 입니다.직장이 일반 한국회사 분위기와는 다르게 모두들 칼퇴근 하는 분위기 이며, 매년 미국 현지 집에 방문할 기간이 충분한 Refresh 휴가, 4대 보험 보장, 시간선택 근무제 와 함께 F-4 비자 소유자(외국인 포함) 들 에게 부분 월세도 지원하고 있어, 해외생활 하셨던 분들에게 편안한 근무환경 입니다.

지원분야, 자격은 하기와 같습니다. 

Position: Clinical Data Associate

Qualification:

1. University/college degree (life science, nursing, or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
2. Familiarity with medical terminology and abbreviations
3. Understanding the instructions of medical coding dictionaries;
4. Minimum one (1) year relevant work experience within a clinical or clinical research environment

Responsibilities:

1. Designs CRF/ eCRF;
2. Creates and updates study-specific documents such as CRF/eCRF, DMP, CRF/eCRF Completion Guidelines.
3. Prepare the Data Validation Specification(DVS), Self Evident Corrections Document(SECD);
4. Create the dummy data according to these specifications;
5. Participates in User Acceptance Testing (UAT) activities for clinical database build and modifications.
6. For paper studies, manage transmittal CRFs and Prepare CRFs for subsequent data entry;
7. For paper studies, review clinical trial data in accordance with Data Validation Specifications and issue Data Clarification Forms (DCFs) to resolve erroneous, missing, incomplete, or implausible data.
8. For paper studies, train and manage data entry staffs in data entry;
9. Perform the medical coding for adverse events, medications, and medical conditions;
10. Performs Serious Adverse Event (SAE) reconciliations.
11. Apply quality control procedures and checks to ensure data quality standards are achieved;
12. Interact and collaborate with project data manager, peers, supervisor, and other project team members;
13. Acts as a client contact person for project meetings and CDM status updates;
14. CDM Audit and Inspection preparation and support

15. Participates in internal/external audits as required.

16.  
17. Position: Dabatase Administrator
18. Qualification:
19. University degree in computer science/information technology, statistics, or a related field.
20. Strong knowledge in the use and administration of SQL and Oracle
21. Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java)
22. Thorough knowledge of database application development

Responsibilities:

1. Creates and updates study-specific documents such as CRF/eCRF, DMP, CRF/eCRF User Manuals.
2. Designs and creates clinical databases to enable data review/validation of the study data by Data Managers, and comprehensive and efficient analysis by Statistics and SAS Programming.
3. Programs and tests database configurations (edit checks, derivations, form/field dynamics, etc.).
4. Programs and tests reports using SQL/SAS to identify inconsistencies and support data review efforts.
5. Perform requirements analysis and system design for clinical data management applications.
6. Perform administrative functions in support of clinical data management, such as access control, security, installation, performance monitoring, and data transfers to customers.
7. Develop and maintain clinical database application procedures, standards, and structural documentation.
8. Produce change control documentation and project plans addressing implementation, validation, maintenance, or modification of databases, including back-out plan as required.
9. Define users and enable data distribution to the right user, in an appropriate format, and in a timely manner
10. Create the Annotated CRF and Database Specification and build the database.
11. Create the DVS and SECD based on the study protocol and CRF.
12. For paper studies, generate and correct data clarification forms (DCFs).
13. Create the dummy data according to these specifications;
14. For paper studies, prepare a data listing for data quality check.
15. For paper studies, train and manage data entry staffs in data entry;
16. Maintain effective communication with project teams, peers, other departments, management, and sponsors.
17. Evaluate database setup and for amount and level of effort and make project assignments accordingly.
18. Maintain user account of the data management application.
19. Serve as a client contact person for project meetings and DBM status updates
20. Interact and collaborate with project data manager, peers, supervisor, and other project team members;
21. CDM Audit and Inspection preparation and support
22. Participates in internal/external audits as required.

제출서류:  영어 이력서, 자기소개서 or 경력기술서 / 희망연봉 (위에 제시한 지원 email 주소 이외에 제 하기 연락처로도 가능합니다)

추가문의 사항이 있으시면 kim.katelin787@gmail.com 으로 편하게 문의 부탁 드리겠습니다. 카톡 아이디 : luv2katelin 로도 연락, 상담 가능합니다. (참고로 저는 한국에서 근무하는 버지니아 교민 입니다)

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