[한국 화이자 제약] Clinical Scientist 채용

외국계 제약 기업

한국화이자 제약에서

Clinical Scientist 1년 계약직을 모집 합니다.

PURPOSE OF POSITION/ROLE

The main responsibility of a Clinical Scientist is managing sites and studies operation including Korea PMS (Post-Marketing Surveillance), Non-Interventional Study (NIS) under his/her responsibility to ensure full compliance with ICH GCP guidelines, Global & Country SOPs, and Korean Regulations

 

1.ORGANIZATIONAL RELATIONSHIP

This position reports directly to Clinical Science & Operation Korea Lead.

 

2.KEY ACCOUNTABILITIES AND RESPONSIBILITIES:

A. Non-Interventional Studies

StudyDesign

• Responsible for developing protocol based on protocol synopsis from NIS Lead in consultation with Medical Research Project Team Lead
• Register assigned study in Corporate Clinical Trials Registry System
• Responsible for developing Case Report Form(CRF) in consultation with NIS Study Lead and Clinical Science & Operation Korea Lead
• Responsible for developing Data Privacy Statement in consultation with NI Study Lead

Study Start-up

• Responsible for identifying sites with inputs from NIS Lead and Clinical Science & Operation Korea Lead
• Develops a detailed project plan with clear milestones & responsibility allocation and risk management strategy in consultation with Clinical Science & Operation Korea Lead
• Responsible for supporting NIS Lead to obtain internal approval of protocol and submit the approved protocol to MFDS as per agreed timeline by NIS Lead
• Responsible for developing project and site level budgets in consultation with Medical Research Project Team Lead (if required by MFDS).
• Prepares and Reviews IRB document and contract (including FCPA requirement if applicable)
• Responsible for Contract Research Organization (CRO) selection and training.
• Oversight Data Management Plan (DMP) and Statistical Analysis Plan (SAP) development by CRO.
• Creating and maintaining of eTMF

Study Conduct

• Ensures appropriate contract and case collection status to meet regulatory requirement in terms of number of cases and timeline in collaboration with CRO.
• Responsible for monitoring of assigned sites, with CRO as applicable
• Monitors project safety reporting status (i.e. SAE follow-up status) from CRO and escalate any potential safety issue to NIS Lead and Clinical Science & Operation Korea Lead.
• Ensures maintaining project tracking tools and preparing regular project updates for internal stakeholders.
• Ensure appropriate distribution of sponsor to site safety information (i.e. LPD update).
• Coordinates with biometrics team/s and/or CRO data management for data management, analysis and report.
• Responsible for submitting regular MFDS report within given timeline

Study Close-out

• Monitors status of data query resolution and safety reconciliation conducted by CRO.
• Provides logistic and administrative support to NIS Lead in finalizing clinical study report
• Responsible for submitting final MFDS report within given timeline
• Provides logistic and administrative support to NIS Lead in finalizing a publication.
• Support NIS Lead to post study result to authorized registry (i.e. clinicalstudyresults.org) within timeline.

 

B. General Responsibilities

• Regular participation in project team meetings.
• Plays pivotal roles or support others in performing Subject Matter Expert (SME) roles, if assigned.
• Responsible for developing performance objectives for the year as well as individual development plan in consultation with direct supervisor.

 

3. SKILLS, KNOWLEDGE, QUALIFICATIONS AND EXPERIENCE

• Bachelor's degree preferably in biological science, pharmacy or nursing.
• Demonstrates understanding of clinical research process.
• Demonstrates understanding of basics of medical/clinical sciences
• Computer skills
• Fluency in English is required.
• Detail orientation
• Interpersonal sensitivity
• Ability to work closely with members of the project team

 

4. COMPETENCIES REQUIRED

• Professional Expertise
• Quality Awareness
• Teamwork
• Communication
• Analytical Thinking
• Planning & organization

Application deadline date: 6/6/2025 6PM Kst.

 

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