Pfizer

SiteActivationPartner(Sr.Associate)

$1500–2500k ~AI est. Taiwan FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Site Activation Partner (Sr. Associate) at Pfizer. Skills: Site Activation, Regulatory Compliance, Document Management. Lead operational activities. Support operational activities”

Industry & Context.

Problems you'll solve

Issue resolution; Problem identification; Problem solving

What They're Looking For.

Must Have

Minimum 4 years relevant experience, Experience in Clinical Trials environment, Experience in clinical site activation, Fluent in Local language, Fluent in English, School diploma/certificate with equivalent combination of education, training and BSA or bachelor’s degree in life sciences

Nice to Have

Bachelor’s degree in life sciences, Experience working in the pharmaceutical industry, Experience working in a CRO, Multilingual capability, Experience working in a global environment, Experience in working in more than 1 country, Experience in leading or participating as an active member of cross functional teams, task forces, Considered for a Centralized EDR for IIP review

What You'll Do.

Lead operational activities

Support operational activities

Ensure compliance with study and country deliverables

Ensure compliance with timelines

Ensure compliance with quality

Manage regulatory activities

Manage ethics activities

Manage essential documents

Initiate activities for IIP compilation

Coordinate activities for IIP compilation

Manage essential documents for IIP compilation

Provide support to resolve issues

Prepare regulatory documents

Validate regulatory documents

Submit regulatory documents

Manage other supporting roles

Coordinate other supporting roles

Coordinate communication with Ethics committee

Document communication with Ethics committee

Respond to Ethics committee

Support investigators sites with IRB workflow

Assist with preparation of clinical documentation

Assist with handling of clinical documentation

Assist with distribution of clinical documentation

Support activities in Shared Investigator Platform

Implement activities in Shared Investigator Platform

Manage documents for protocol amendments

Manage documents for FDA 1572/Attestation revisions

Manage documents for Ethics Committee annual approvals

Manage other regulatory activities

Ensure maintenance of IRB/Ethics activities

Ensure maintenance of other committees’ activities

File documents to Trial Master File

Assist with periodic quality review of study files

Update clinical trial systems

Maintain clinical trial systems

Support investigator sites for audits/inspections

Support study teams for audits/inspections

Provide responses for site audits/inspections

Provide responses for study audits/inspections

Maintain ongoing contact with study team

Maintain ongoing communication with study team

Respond to study team requests

Respond to investigator site requests

Provide functional updates

Utilize tools for efficient updates

Disseminate Central Ethics Approval

Disseminate Local Ethics Approval

Communicate Local sites approvals

Perform awareness session with site personnel

Ensure ongoing compliance with study documentation

Identify investigator site issues

Resolve investigator site issues

Align on corrective actions

Align on preventative actions

Act as Site Activation Partner Point of Contact

Represent SAP function

Represent SAP role on global initiatives

Act as SME on projects

Act as SME on initiatives

Support mentoring of new hires

How You'll Work.

Team & Collaboration

Cross-functional teams; Study team; Local country colleagues

Communication Scope

Verbal communication; Written communication

Process & Methodology

Study start-up, Study conduct, Study close-out

Full Job Description

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

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