The Clinical Scientist manages site operations for non-interventional studies, ensuring compliance with regulations and overseeing project timelines and budgets.
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
Study Design
Study Start-up
Study Conduct
Study Close-out
B. General Responsibilities
3. SKILLS, KNOWLEDGE, QUALIFICATIONS AND EXPERIENCE
4. COMPETENCIES REQUIRED
Application deadline date: 6/6/2025 6PM Kst.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
#LI-PFE
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
Study Design
- 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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
#LI-PFE
Top Skills
Clinical Trials Registry System
Data Management Plan
Etmf
MS Office
Statistical Analysis Plan
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