Pfizer

Site Activation Partner (Sr. Associate)

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Seoul, KOR

Hybrid

Mid level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

The Site Activation Partner leads operational activities for clinical studies, ensuring compliance with regulatory requirements and coordination of site activation processes.

Summary Generated by Built In

The Site Activation Partner is responsible for leading and supporting operational activities from start-up to close-out, for assigned studies and investigator sites ensuring compliance with study and country deliverables, timelines and quality in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.
Primary scope of work related to Regulatory, Ethics and Essential documents management activities through the life cycle of the study.
Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs.
JOB RESPONSIBILITIES

Clinical Trial Site Activation:
Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site activation
Provide support to resolve issues or concerns and timely escalation of Site issues where applicable
Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
Manage and coordinate with other supporting roles to ensure timely site activation and execution of operational activities.
Support the compilation of the Central/and or Local Investigator Review Board (IRB) package and submissions to approval of the study ( where applicable ) and other committees as per country requirements
Coordinate the timely communication, documentation and responses between Pfizer and Central/Local Ethics committee to bring clinical study to approval (country dependent)
Support investigators sites with local IRB workflow from preparation, submission through approval
Assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures.
Support & implement in-scope activities in Shared Investigator Platform to align with Pfizer strategy

Clinical Trials Conduct:
Post site activation, initiate and coordinate activities and essential documents management with the investigator's sites towards the compilation of a high-quality documents and updates through the life cycle of a study such as.
the documents management and approvals for protocol amendments,
- FDA 1572/Attestation revisions,
- Ethics Committee annual approvals
- other regulatory activities required during study conduct
Ensure maintenance of IRB/Ethics and other committees' activities as applicable
Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness
Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections

Internal & External Communication:

Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests
Provide functional updates on a country and site level as required
Utilize tools for efficient updates to study teams and SAP functional line as needed regarding site status, issues, delays, approvals
Disseminate Central or Local Ethics Approval to study team and Investigator Sites where applicable=
Communicate Local sites approvals to study team members and stakeholders
As needed, perform, awareness session with site personnel on Pfizer requirements to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Pfizer standard
Identify and resolve investigator site issues timely; align with study team and local country colleagues on corrective and preventative actions

Additional Responsibilities:

A good understanding of the Site Activation requirements and processes within the country/region and be able to learn and potentially implement in more than one (1) country
May be assigned as Site Activation Partner Point of Contact (PoC) on a study within a country
May be assigned as an SME on a system and/or process, and represent the SAP function as applicable
May represent the SAP role on global initiatives
May be considered for a Centralized EDR for IIP review (quality dependent)
Able to act as an SME on projects and initiatives, as requested
Support the mentoring of new hires on processes/ systems

Systems & Tools:

Ability to independently use, and learn new systems
Microsoft Suite
Clinical Trial Management Systems (Veeva CTMS)
Veeva Suite
Electronic Trial Master File
Document exchange portals
Ethics, National Networks and Governing Bodies Portals and platforms (as needed)

Work Location Assignment: Remote
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical

Skills Required

Experience with clinical trial processes and regulations
Proficiency in clinical trial management systems
Ability to communicate effectively with stakeholders
Understanding of Good Clinical Practices
Familiarity with Pfizer standards

What the Team is Saying

Pfizer Compensation & Benefits Highlights

Parental & Family Support — U.S. materials describe up to 26 weeks of parental leave (including up to 12 paid non‑medical weeks), with phased return‑to‑work plus fertility, adoption, and surrogacy financial support, backup care, lactation support, and caregiver leave. These offerings indicate depth in family‑building benefits and day‑to‑day caregiver resources.
Healthcare Strength — Core programs commonly include medical, prescription drug, dental, vision, mental‑health/EAP resources, disability insurance, preventive health programs, and free or reduced‑cost vaccinations. Voluntary Benefit Extras and wellness resources broaden coverage and access.
Retirement Support — Career pages and postings note a 401(k) with company matching plus an additional company retirement savings contribution in some plans. Company materials also reference financial‑planning education and colleague‑directed retirement funds.

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.