서울 명동에 위치하고 있는 임상시험 회사, LSK GLOBAL PS (엘에스케이글로벌파마서비스) 에서 영어에 능통한 교민출신 직원을 채용 중 입니다. 

혹 본인이나 자녀분들이 한국에서 지내며 직장경험을 쌓고 싶으시다면 정말 좋은 기회 입니다. 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:

• 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)
• Familiarity with medical terminology and abbreviations
• Understanding the instructions of medical coding dictionaries;
• Minimum one (1) year relevant work experience within a clinical or clinical research environment

Responsibilities:

• Designs CRF/ eCRF;
• Creates and updates study-specific documents such as CRF/eCRF, DMP, CRF/eCRF Completion Guidelines.
• Prepare the Data Validation Specification(DVS), Self Evident Corrections Document(SECD);
• Create the dummy data according to these specifications;
• Participates in User Acceptance Testing (UAT) activities for clinical database build and modifications.
• For paper studies, manage transmittal CRFs and Prepare CRFs for subsequent data entry;
• 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.
• For paper studies, train and manage data entry staffs in data entry;
• Perform the medical coding for adverse events, medications, and medical conditions;
• Performs Serious Adverse Event (SAE) reconciliations.
• Apply quality control procedures and checks to ensure data quality standards are achieved;
• Interact and collaborate with project data manager, peers, supervisor, and other project team members;
• Acts as a client contact person for project meetings and CDM status updates;
• CDM Audit and Inspection preparation and support
• Participates in internal/external audits as required.

Position: Dabatase Administrator

Qualification:

• University degree in computer science/information technology, statistics, or a related field.
• Strong knowledge in the use and administration of SQL and Oracle
• Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java)
• Thorough knowledge of database application development

Responsibilities:

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

추가문의 사항이 있으시면 kim.katelin787@gmail.com 으로 언제든 편하게 연락 부탁 드리겠습니다.